Quality Control Laboratories Research Articles

Enhancing Sulfinpyrazone determination via Electrochemistry: Development of a S-Doped CoFe2O4 Modified Sensor

Abstract An electrochemical sensor for the electrochemical determination of Sulfinpyrazone (SFP) was developed based on ferrite, a Sulphur-doped Cobalt Ferrite (S- CoFe2O4), functionalized glassy carbon electrode (GCE). SFP displayed remarkably increased electrochemical activity on the S-CoFe2O4 modified GCE as the modifier enhances the surface area and electrocatalytic activity. Characterization of the electrode modifier was carried out through XRD and SEM-EDS analyses. Cyclic voltammetry (CV) and square wave voltammetry (SWV) were utilized to explore SFP analysis. The optimum immersion time for the study was found to be 20 seconds. An enhanced oxidation of SFP was noticed at a pH of 7.4 for the investigation between the potential range of 0 to 1.0 V. The process displayed irreversible and diffusion-controlled nature. Under ideal experimental conditions, the oxidation peak current of SFP showed a direct proportionality to its concentration within the range of 1.0 to 10 µM, with a detection limit of 2.45 nM. This sensor effectively determines the determination of SFP in pharmaceutical products, yielding satisfactory results in terms of recovery, stability, and sensitivity. This approach creates opportunity for exploration in the electrochemical investigation of SFP. These findings suggest that the constructed sensor could be useful in pharmacokinetic studies and quality control labs.

Expert consensus on the standardized application of whole exome sequencing technology in diagnosis of genetic disorders

Next generation sequencing (NGS) technology is playing an increasingly important role in the diagnosis of genetic diseases. Whole exome sequencing (WES) which targets the coding regions of the genome has been widely used in the diagnosis of genetic diseases for its low cost and high efficiency. However, compared to conventional methods, the NGS process is intricate, and there is variability in the expertise of data analysts and variant interpreters, which may lead to inconsistencies in the outcomes. To ensure the quality of testing and enhance the diagnostic rate of diseases, this consensus has provided recommendations regarding the laboratory setup, operational procedures, data analysis, result interpretation, and quality control for WES, with an aim to standardize its application in the detection of genetic disorders.

Greenness Assessment of High‐Performance Liquid Chromatography Method for Simultaneous Estimation of Apigenin, Apocynin, and Gallic Acid With Quality by Design Approach

ABSTRACTThis study presents the development of an eco‐friendly high‐performance liquid chromatography (HPLC) method for the simultaneous determination of apigenin, apocynin, and gallic acid, integrating analytical quality by design (AQbD) and green analytical chemistry (GAC) principles. The objective was to enhance method efficiency while reducing environmental impact, energy consumption, and solvent use. An AQbD approach was employed, starting with quality risk assessment and scouting analysis, followed by optimization using Box–Behnken design (BBD) to screen three key chromatographic parameters. The optimal chromatographic conditions were determined using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase of methanol: water (80%:20% v/v), a flow rate of 1 mL/min, ultraviolet detection at 228 nm, and a temperature of 25°C. The method demonstrated linearity over a concentration range of 1–5 µg/mL for the target compounds, with gallic acid as an internal standard. The method's greenness profile was assessed using various evaluation tools, confirming its compliance with GAC principles. The results indicate that the proposed HPLC method is not only effective and reliable but also environmentally sustainable, making it suitable for routine use in quality control laboratories. The integration of AQbD and GAC principles highlights the method's contribution to more sustainable and efficient analytical practices.

Implementation of Occupational Safety and Health at PT Menarini Indria Laboratories Bekasi

PT Menarini Indria Laboratories, a foreign pharmaceutical company in Indonesia, recognizes the importance of occupational safety as a critical step toward operational success. A significant focus on the Quality Control (QC) division and the Quality Control Laboratory, where drug quality testing is conducted, presents potential hazards to employees. Through the implementation of ISO 45001:2018 Standard, the company demonstrates its commitment to occupational safety and health. The results showed an excellent level of ISO 45001:2018 implementation with percentage values above 78% for each step of the PDCA cycle. Hazard Identification and Risk Assessment (HIRA) analysis helped identify potential hazards and risks in QC. Some areas, such as the use of heavy equipment, chemical spills, and laboratory operations, showed a level of risk that needed to be managed appropriately. The company has implemented appropriate controls, such as SOPs, ergonomics training, use of assistive devices, and personal protection (PPE). Proactive measures such as the Zero Accident Program and annual external audits are also implemented to achieve safety goals. Nonetheless, the company must continuously monitor and improve its safety management system to ensure a safe, efficient, and compliant working environment. By aligning ISO 45001:2018 implementation and risk mitigation strategies, PT Menarini Indria Laboratories can ensure continued operational success while providing optimal protection for its workforce.

Comprehensive Review of Laboratory Automation, Quality Control, And Workforce Adaptation

There is a very close relationship that exists between the increased use of automation technology and the quality of diagnosis as well as the efficiency of the laboratory. Therefore, this review intends to describe the current position of automation for laboratory facilities and sample analysis and investigate its impact on quality control (QC), efficiency, and workforce flexibility. Automated technologies have been integrated into all functional ranges, beginning from sample management to result determination, increasing the sample & result turnaround time and accuracy. Nevertheless, automation and incorporation of technologies in laboratories have their own issues, such as quality assurance, human resource changes, and flow process challenges. This review summarizes the current literature with advances in laboratory automation, quality control, and workforce management, together with implications for the future of laboratories in clinical and research settings.

Identification and Characterization of Acidic Degradation Products of Moxidectin Drug Substance Including Degradation Pathways Using LC, HRMS, and NMR.

Moxidectin is an active pharmaceutical ingredient (API) extensively used in various drug products within the pharmaceutical and animal health sectors. Despite its widespread use, the analytical methods prescribed by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP, Ph. Eur.) exhibit significant limitations. These methods fail to adequately separate key impurities of (23Z)-moxidectin (EP impurity L) and 3,4-epoxy-moxidectin, potentially affecting the quality control, purity assessment, and safety of moxidectin-containing products. The objective was to develop and validate an alternative, improved stability-indicating HPLC method for the identification, assay, and quantification of related substances in the moxidectin drug substance, along with the analysis of its degradation pathways. High-Resolution Mass Spectrometry (HRMS) and Nuclear Magnetic Resonance (NMR) were employed to comprehensively examine moxidectin and its two degradation products under specified acidic conditions. The degradation products were isolated and identified using a range of analytical techniques, including HRMS, NMR, and other relevant methods. The epoxy derivative of moxidectin (RRT = 1.2) was not identified under the studied acidic degradation conditions. HRMS data indicated that the degradant at RRT = 1.2 is an isomer of moxidectin, as it exhibited an identical molecular ion. Detailed NMR studies on moxidectin and its impurity at RRT-1.2 revealed differences in carbon and proton chemical shifts at positions C-22 and C-24, strongly supporting the identification of the structure as an oxime geometric isomer of moxidectin, ie, (23Z)-moxidectin. The findings revealed specific degradation products formed under acidic conditions, offering valuable insights into the chemical transformations of moxidectin. This information is crucial for assessing the drug's stability profile and ensuring the quality and safety of moxidectin-containing products. The HPLC method developed in this study significantly improves upon existing USP/EP methods with regard to a separation of key impurities of (23Z)-moxidectin and 3,4-epoxy-moxidectin, offering robust performance for routine analysis of bulk moxidectin API batches and stability samples in quality control (QC) laboratories.

Capillary Electrophoresis with Diode Array Detection for the Quantification of Triptorelin and Lanreotide in Pharmaceutical Quality Control: Development, Validation, Greenness and Practicality Evaluation

Abstract Aim Capillary electrophoresis (CE)-based methods hold significant potential for routine use in pharmaceutical quality control (QC) laboratories. Therefore, this study aimed to develop a novel, green, and simple hydrodynamically open-system capillary zone electrophoresis method with diode-array detection (CZE-DAD) for the simultaneous analysis of lanreotide and triptorelin in a single electrophoretic run and to objectively evaluate the analytical technique’s greenness and practicality for application in the pharmaceutical QC settings. Materials and Methods The two therapeutic peptides were analysed using a commercially available CZE-DAD analytical system. The separation process was optimised by changing the composition and concentration of the background electrolyte (BGE). The developed method was validated in accordance with the International Conference on Harmonisation (ICH) Q2(R1) guidelines, and Diphereline® (powdered form for injection, 0.1 mg of triptorelin acetate) was used as a real dosage form of triptorelin. Greenness and practicality were evaluated using Green Analytical Procedure Index (GAPI), Analytical GREEnness (AGREE), and Blue Applicability Grade Index (BAGI) metrics. Results The optimised method utilised 250 mmol/L formic acid as the BGE, achieving high separation efficiency and short migration times, where both the peptides were analysed in <5 min. The method showed excellent linearity (r 2 > 0.99), precision (relative standard deviation [RSD] <7.1%), and accuracy (92.7%–113.6%). The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.5 μg/mL and 2 μg/mL, respectively. The method was also found to be environmentally friendly, with high scores achieved in both the GAPI and AGREE assessments, while also being practical, with a BAGI score of >60. Conclusions The newly developed CZE-DAD method proved to be a reliable, efficient, and environmentally sustainable alternative to liquid chromatography (LC)-based methods for the analysis of lanreotide and triptorelin. The method’s acceptable validation parameters and favourable greenness and practicality scores support its high application potential in pharmaceutical QC laboratories.

In vitro comparative quality evaluation of different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia.

The incidence of hypertension in persons 25 years of age and older is estimated to be 46% in Africa, where it is still very common. This concerning rate could be explained by the pharmaceutical markets' accessibility to poor quality antihypertensive drugs. Thus, the purpose of this study was to evaluate and compare the quality different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia. The quality control test was conducted from August 30, 2019 to February 27, 2020 at Jimma University in the Laboratory of Drug Quality Control (JuLaDQ). The laboratory test was carried out in accordance with WHO inspection guidelines and United States Pharmacopeia. A statistically significant was considered when P<0.05. For further comparison of the in-vitro dissolution profiles of amlodipine tablets, model-independent model-dependent parameters and statistical Dunnetts tests for ensuring bioequivalence were used to further compare the in-vitro dissolution profiles. With the exception of brand AMD-5 (1/10), the remaining nine (n = 9) brands were within WHO visual inspection criteria. The quality control parameters such as friability, weight variation, identity, assay, and dissolution test were within the United States Pharmacopeia. The model independent parameters (f1, and f2) confirmed that, all generic products were bio-equivalence, and interchangeable with comparator product. The model dependent approaches revealed the Weibull model (AMD-10), the Zero order (AMD-3), and the Korsemeyer-Peppas models were the most effective predictions for the release of the pharmaceutical substance from the dosage form. The Korsemeyer-Peppas model (r2 ≥0.9695) was the best descriptive model for determining the amlodipine drug kinetics from the point of view of all brands examined. The evaluated amlodipine brand tablets were in line with quality standards. The model independent methods confirmed that the generic brand tablets were interchangeable in clinical practice. The tested products follow more than two drug release kinetics. The study revealed a manifest discrepancy in the dissolution profiles' releases. Therefore, it is strongly advised to use appropriately designed dissolution profile evaluation methods with various pH values in the dissolution media, as well as to do comprehensive visual inspections. This will make it easier to do a thorough investigation of any potential quality issues that might be related to various generic products available in the pharmaceutical market.

Screening Methods for Antimicrobial Residues in the Dairy Chain-The Past and the Present.

The presence of residues of antimicrobial substances in milk has been an important hygienic and technological parameter of raw milk quality since the 1960s. The presented review focuses on screening methods (microbiological inhibition methods and rapid specific tests) that are used in the control of antimicrobial residues in milk in the context of their historical development up to the present. We briefly explain the principles of the methods and discuss their pros and cons. The aim was to provide both the historical perspective on this topic and provide useful information on screening methods that are currently routinely used for the detection of residues of antimicrobials at farms, in the dairy industry, and in milk quality control laboratories.

Development of HPLC-UV method for determination of Nilotinib in spiked human plasma with greenness assessment

One of the approved second-generation tyrosine kinase inhibitors (Nilotinib) shows great efficacy and selectivity in the treatment of patients with chronic or accelerated phase chronic myelogenous leukemia, and in resistant/ intolerant to prior therapy cases. For the analysis of Nilotinib in synthetic mixture and human plasma samples, a new reversed-phase high-performance liquid chromatographic method was developed. Determination was performed successfully using RP–18 column and a mobile phase consisting of 10 mM potassium dihydrogen phosphate buffer (pH = 5.5), methanol, and acetonitrile in the ratio 37:37:26 (v/v/v). Isocratic mode of elution with flow rate 1.2 ml/min and UV detection at 265 nm were applied. The method was validated for linearity in the range 0.5–24.0 µg/ml and best accuracy and precision results were obtained at temperature 40 °C. The percentage recovery of the analyzed drug was in the range 88.0–106.0 %. Moreover, the proposed RP-HPLC method was evaluated in terms of greenness, whiteness and blueness using three newly developed ecological metrics – The Analytical Greenness software, White Analytical Chemistry and Blue Applicability Grade Index. Good results were obtained and the technique was proved effective, specific and suitable for implementation in routine quality control and clinical laboratory practice for therapeutic drug monitoring.

Spectral resolution techniques for the simultaneous spectrophotometric determination of anti-Parkinson drugs in their combined pharmaceutical dosage form and biological sample based on multivariate calibration and absorbance subtraction methods

In this study, simultaneous determination of levodopa (LEV) and carbidopa (CBD) in binary mixtures, pharmaceutical formulation, and biological sample was conducted using the application of simple, fast, sensitive, and accurate UV-spectrophotometry in combination with chemometrics methods. The first method is net analyte signal (NAS) based on the multivariate calibration methods. The limit of detection (LOD) and limit of quantification (LOQ) were 0.9758, 0.7633 µg/mL and 2.956, 2.313 µg/mL over the linear range of 5–40 and 0.5–20 µg/mL for LEV and CBD, respectively. In the NAS approach, the mean recovery values of mixtures were 100.12 % for LEV and 99.65 % for CBD, where root mean square error (RMSE) values were 0.0106 and 0.0141 for LEV and CBD, respectively. The second method is absorbance subtraction (AS) based on the absorption factor technique for analyzing the isosbestic point. This model was constructed at an isosbestic point of 261 nm in the range of 5–40 and 0.5–20 µg/mL with coefficient determination (R2) of 0.9985 and 0.9996 for LEV and CBD, respectively. AS method could estimate LEV and CBD with LOD values of 1.924 and 0.5657 μg/mL and LOQ values of 5.833 and 1.714 μg/mL, respectively. The recovery percentage was between 91.50 % to 104.60 % with RMSE of 0.1455 for LEV and 92.00 % to 106.66 % with RMSE of 0.2508 for CBD. The introduced approaches have the benefit of concurrent analysis of the mentioned components without any pretreatment. Statistical comparison of the results of real sample analysis with high-performance liquid chromatography (HPLC) did not show a significant difference. These methods can replace HPLC in quality control laboratories when fast, precise, and low-cost analysis is needed.

Advanced HPTLC Method Development for Silibinin Analysis in Nanoformulated Scaffolds: A Box-Behnken Approach.

Silibinin (silybin), a bioactive component derived from the seeds of milk thistle (Silybum marianum), is recognized for its diverse pharmacological properties, including antioxidant, anti-inflammatory, and hepatoprotective effects. Given its therapeutic significance, accurately quantifying silybin in various formulations is essential. High-performance thin-layer chromatography (HPTLC) is a powerful analytical technique frequently used for this purpose. In this study, an HPTLC method was validated according to the International Council for Harmonization (ICH) guidelines to determine the concentration of silybin. The design of experiments (DoE), specifically the Box-Behnken design, was employed to optimize and understand the influence of critical method variables. The HPTLC method validation was performed using silica gel F254 HPTLC plates. The variables investigated included the composition of the mobile phase (% v/v), saturation time (minutes), and temperature in degree Celsius (°C), with the Box-Behnken design for optimization. The mobile phase consisted of chloroform, acetone, and formic acid in a 7:2:1 (v/v) ratio. Both the formulated scaffold and standard drug were applied to the plates, which were then processed in a twin chamber. After development, the plates were scanned at 288 nm using the Camag TLC Scanner IV with Vision CATS software. The validated HPTLC method demonstrated a strong linear relationship within the silybin concentration range of 2-10 μg/mL. The limit of detection (LOD) and limit of quantification (LOQ) for silybin were determined to be 0.469 and 1.423 μg/mL, respectively. Recovery studies indicated that the method provided accurate quantification, with recovery rates ranging from 97.53% to 99.82%. These results confirm the method's high accuracy, outstanding linearity, and reliability for the quantification of silybin in formulations. The validated HPTLC method proved to be a reliable analytical tool for the quantification of silybin in various formulations, particularly those containing polymers. The method's strong linearity, precision, and accuracy align with the ICH guidelines, making it suitable for routine analysis in quality control laboratories. The use of the Box-Behnken design for method optimization highlights the importance of systematic experimentation in achieving robust analytical outcomes.

Simultaneous determination of amoxicillin, clarithromycin, and vonoprazan fumarate in a ternary mixture using double divisor ratio spectra and first derivative zero crossing techniques

Two new spectrophotometric methods were developed based on a double divisor ratio spectra and first derivative zero crossing for the determination of Amoxicillin (AMX), Clarithromycin (CLM) and Vonoprazan Fumarate (VNP) in their prepared mixtures without previous separation. Double Divisor (Method A); this method depends on dividing the peak responses of AMX with the sum of peaks of CLM and VNP in concentrations of 400.0 μg/mL and 10.0 μg/mL, respectively, at λmax = 289 nm. Similarly, CLM and VNP peaks are recorded at 290 nm and 250 nm, respectively. Method B: Accordingly, peak responses of AMX and CLM were divided by 10.0 μg/ mL VNP and the peak responses of VNP and CLM were divided by 200.0 μg/mL AMX. This work holds significance as it marks the first instance of determining the mixture through either method. GAPI and AGREE approaches were used for environmental sustainability of the proposed approaches, which authenticated the methods to be eco-friendly. The limit of detection (LOD) and quantification (LOQ) for Methods A was 6.13 μg/ mL and 18.65 μg/mL for AMX, 5.12 μg/mL and 15.5 μg/mL for CLM, and 0.0975 μg/mL and 0.296 μg/mL for VNP, respectively. Along with the present method B were 4.219 μg/mL and 12.78 μg/mL for AMX, 4.57 μg/ mL and 13.84 μg/mL for CLM and 0.098 μg/mL and 0.296 μg/mL for VNP, respectively. These Simple, validated methods with green characteristics should be envisaged for quality control laboratories.

Ion-chromatographic determination of common anions in drinking water in some regions of the Republic of Armenia

The present study investigated the anion composition of drinking water from various cities and villages in Armenia, including spring water and tap water samples. The simultaneous separation was achieved for fluoride, chloride, bromide, nitrite, nitrate, sulfate, and phosphate anions with the correlation coefficients &amp;gt;0.998. Validation of the method was carried out in accordance with the requirements of guidelines in terms of selectivity, specificity, system suitability, linearity, accuracy, precision, lower limits of detection and quantitation, robustness, and stability. The method was suitable for routine drinking water quality assessment in line with the national or World Health Organization (WHO) regulations. The validated method was further used to analyze drinking water samples from different regions of Armenia. The observed concentrations for the anions in drinking water complied with the WHO limits for drinking water with some exceptions. The test method can be submitted to quality control laboratories as a convenient and practical tool for routine analysis and monitoring studies.

QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories.

Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices. QC Constellation, a web application built using Python 3.11, integrates various statistical QC modules. These include Levey-Jennings charts with Westgard rules, sigma-metric calculations, exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) charts, and method decision charts. Additionally, it offers a risk-based QC section and a patient-based QC module aligning with modern QC practices. The codes and the web application links for QC Constellation were shared at https://github.com/hikmetc/QC_Constellation, and http://qcconstellation.com, respectively. Using synthetic data, QC Constellation demonstrated effective implementation of Levey-Jennings charts with user-friendly features like checkboxes for Westgard rules and customizable moving averages graphs. Sigma-metric calculations for hypothetical performance values of serum total cholesterol were successfully performed using allowable total error and maximum allowable measurement uncertainty goals, and displayed on method decision charts. The utility of the risk-based QC module was exemplified by assessing QC plans for serum total cholesterol, showcasing the application's capability in calculating risk-based QC parameters including maximum unreliable final patient results, risk management index, and maximum run size andoffering risk-based QC recommendations. Similarly, the patient-based QC and optimization modules were demonstrated using simulated sodium results. In conclusion, QC Constellation emerges as a pivotal tool for laboratory professionals, streamlining the management of quality control and analytical performance monitoring, while enhancing patient safety through optimized QC processes.

Streamlined turn-off fluorescence sensing of Donepezil: Enhancing evaluation in pharmaceutical formulations, quality control labs, and biological fluids at nano levels

Donepezil (DPZ) is used to treat Alzheimer’s disease by increasing acetylcholine in the brain, necessitating precise analytical methods for its evaluation. This study aims to develop and validate a new turn-off fluorescence sensing method for quantifying DPZ, enhancing its evaluation in pharmaceutical formulations, quality control laboratories, and biological fluids. By leveraging the fluorescence-quenching interplay between DPZ and tetrabromofluorescein, the assay parameters were fine-tuned to enhance the development of an ion-associated complex. The developed method demonstrated a measurement range from 40.0 to 800.0 ng/mL, with detection and quantification limits of 12.6 ng/mL and 38.0 ng/mL, respectively. However, the successful application of the method to commercial DPZ tablets and plasma samples confirmed its effectiveness for both quality control labs and clinical research settings. It ensured accurate content uniformity and high precision, making it ideal for routine DPZ monitoring. In contrast to previous methods, this approach emphasizes environmental sustainability, evaluated using advanced tools like the Eco score scale, AGREE, RGB12, and BAGI. These tools facilitated a thorough assessment of the method’s ecological impact and sustainability, underscoring its advantage over traditional methods in terms of environmental responsibility.

Development and Validation of Trace Level Quantification of Nine Azido Genotoxic Impurities in Losartan Potassium Active Pharmaceutical Ingredients by Liquid Chromatography‐Tandem Mass Spectrometry

ABSTRACTThe objective of the study is to develop a sensitive and simple liquid chromatography‐tandem mass spectrometry for the determination of nine azido impurities in Losartan potassium active pharmaceutical ingredients. An advanced analytical method should be developed to determine these nine Azido impurities at 0.5 ppm level. Currently, no such method is reported to control these impurities in losartan potassium drug substance. The nine impurities separation was achieved using Hypersil ODS stationary phase with gradient elution and mobile phase of 0.1 M ammonium acetate as mobile phase A and methanol as mobile phase B. The developed method was found to be sensitive to the limit of detection and limit of quantitation levels as per the International Council for Harmonization M7 guidelines. The method was linear from 0.5 ppm to 15 ppm for all nine azido impurities. This is a single method for the simultaneous determination of all azido impurities in the presence of losartan potassium drug substance at 0.5 ppm and the same method used in the quality control laboratory for sample analysis.

Performance Characteristics of the Quantitative Method for Staphylococcus aureus in Food Products Correspond to ISO 16140-3: 2021

Staphylococcus aureus is a pathogenic bacterium that poses significant health risks when present in food products. High levels of Staphylococcus aureus in food can indicate poor hygiene and handling practices during food production, processing, or storage. In order to maintain food safety and quality, verification of the quantitative method of Staphylococcus aureus is very important. Method verification represents a crucial stage in guaranteeing that all employed procedures conform to the necessary criteria for dependable and precise data. Following the guidelines established in ISO 16140-3:2021, method verification is accomplished through the calculation of the Intralaboratory Reproducibility Standard Deviation (SIR) for implementation validation and the eBias value for verifying the suitability of the method for assessing specific food items. This research was conducted with the objective of confirming the ISO 6888-1:2021 as the designated reference method for quantifying Staphylococcus aureus in food products. For the purpose of confirming the implementation of the method, Cheese was utilized as the test food item. In the context of verifying the method's applicability to different food products, a range of items including condensed milk, margarine, baby porridge, cassava chips and ready-to-eat sausage were examined as challenging foods. Every chosen food item was artificially contaminated with Staphylococcus aureus WDCM 00034. The SIR value obtained was 0.04 ≤ 2× 0.11 (the lowest mean of SR value from ISO 6888-1:2021) which indicated that the National Quality Control Laboratory of Drug and Food (NQCLDF), Indonesian FDA was able to implement the method very well. In addition, the eBias value for all types of food tested was below 0.5log10, which showed that the quantitative method for coagulase-positive Staphylococci (Staphylococcus aureus and other types) could be applied in the NQCLDF laboratory for the extensive scope of food.

Advanced HPLC Method with Diode Array Detection Using a Phenyl-Bonded Column for Simultaneous Quantitation of Three Sunscreen Filters in a Moisturizing Sunscreen Cream for Acne-Prone Skin

This study introduces a novel, robust, and efficient method for the simultaneous quantitative determination of three sunscreen filters, namely, 4-methylbenzylidene camphor, octyl methoxycinnamate, and avobenzone, in a moisturizing sunscreen cream specifically designed for acne-prone skin. The method employs high-performance liquid chromatography with photodiode-array detection, providing a reliable separation of the analytes. Chromatographic separation was achieved using a Fortis Phenyl analytical column (150.0 × 2.1 mm, 5 μm), with isocratic elution at a flow rate of 0.4 mL/min. The mobile phase was composed of a 57/43 (v/v) mixture of acetonitrile/45 mM aqueous ammonium formate solution, ensuring sufficient resolution and peak symmetry for the target compounds. The method was validated comprehensively for critical performance parameters, including linearity, precision, accuracy, and robustness. Linearity was established across a suitable range for all three analytes, with high correlation coefficients. Precision was confirmed with intra-run and total precision coefficients of variation of ≤4.6%, while accuracy assessments yielded a percent recovery between 98.6 and 100.4, for all quality control levels. Additionally, the method was able to effectively separate the sunscreen filters from other cosmetic ingredients, such as [β-(1.3), (1.6)-D-glucan], low molecular weight (LMW) hyaluronic acid and plant extracts ensuring specificity in complex formulations. This straightforward and time efficient sample preparation process, involving methanol extraction followed by serial dilution, makes the method suitable for routine quality control in cosmetic laboratories. The method was successfully applied to the analysis of two different lots of a commercial sunscreen cream, achieving excellent recovery for all filters, ranging between 94.6% and 99.8%, thus demonstrating its reliability and applicability for the quality control of cosmetics.

First fluorescence method for monitoring the doping stimulant drug solriamfetol in plasma and urine: A pharmacokinetic study in volunteers’ urine with greenness, whiteness, and blueness assessments

A green, sustainable, simple, and highly sensitive spectrofluorimetric method was developed to determine solriamfetol hydrochloride for the first time in biological fluids and dosage form. To the best of our knowledge, no Fluorimetric methods have been reported for solriamfetol determination in plasma and urine. The method is based on measuring the intrinsic fluorescence of solriamfetol hydrochloride at 522 nm after excitation at 260 nm in ammonium acetate buffer solution at pH 4. All factors influencing the response have been carefully investigated. The method was linear over a concentration range of 10 to 1800 ng/mL (r = 0.9998). The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 3.2 and 9.8 ng/mL, respectively, indicating the excellent sensitivity of the proposed method. The pharmaceutical dosage form, spiked human plasma, and urine samples were successfully analyzed using the described method with average recoveries of 99.79 ± 0.739, 99.27 ± 1.885, and 99.57 ± 1.701, respectively. Plasma samples were first subjected to protein precipitation using 10 % perchloric acid, while urine samples were analyzed directly without any pretreatment. Furthermore, the suggested method was applied effectively on real human volunteers’ urine to measure renal clearance, the cumulative amount of solriamfetol excreted unchanged in the urine, and the percent of the dose recovered. The eco-friendly nature and sustainability of this work were evaluated using trending greenness, whiteness, and blueness assessment metrics. The greenness assessment tools, namely the Analytical GREEnness metric tool (AGREE), Analytical Eco-scale, and complementary green analytical procedure index (complex GAPI) were selected to prove the eco-friendly nature of the method. Additionally, whiteness and blueness assessments were conducted using the Red-Green-Blue model (RGB model), and high Blue Applicability Grade Index (BAGI), respectively. The proposed method is a promising analytical tool for routine analysis in quality control labs, therapeutic drug monitoring, and pharmacokinetics studies.