Pharmaceutical Formulations Research Articles

Cyclodextrin-Containing Drug Delivery Systems and Their Applications in Neurodegenerative Disorders

Cyclodextrins (CDs) are ubiquitous excipients, constituted of cyclic glucopyranose units, and possess a unique dual nature, that of a hydrophobic interior and a hydrophilic exterior. This enables their interaction with lipid-affinitive compounds and hydrophilic compounds, thereby augmenting their application in pharmaceutical formulations as agents for improving solubility, as well as fundamental elements of advanced drug delivery systems. Additionally, CDs, upon suitable modification, can strategically participate in the interaction with cellular components and physical barriers, such as the blood–brain barrier, where their intricate and multifunctional engagement leads to various biological impacts. This review consolidates the crucial features of CDs and their derivatives, and summarizes the applications of them as drug delivery systems in neurodegenerative disorders, emphasizing their notable potentials.

Milestones in the Technology of Modified Starch in Pharmaceutical Formulation

Abstract: Carbohydrates, the most prevalent class of organic substances in living systems, play a variety of important roles, such as in the creation of energy, the construction of biological structures, and the synthesis of paper and food. More advanced uses of modified starch have been introduced over the past millennium, demonstrating that modified starches are promising excipients in drug delivery, an area in which their role and range of utility continuously increase. Technological advancements in the pharmaceutical field have led to the development of new and highly stable molecules with enhanced properties for novel drug delivery systems. Innovative starches from various sources present exclusive support in the development of novel dosage forms.

Resveratrol's bibliometric and visual analysis from 2014 to 2023.

Resveratrol (RSV) is a natural polyphenolic compound derived from a variety of plants that possesses a wide range of biological activities, including antioxidant, anti-inflammatory, antitumor, antibacterial, antiviral, anti-aging, anti-radiation damage, anti-apoptosis, immune modulation, regulation of glucolipid metabolism, inhibition of lipid deposition, and anti-neuro. It is therefore considered a promising drug with the potential to treat a wide range of diseases. In this study, using Web of Science Core Collection (WoSCC) and CiteSpace bibliometric tool, VOSviewer quantitatively visualized the number of countries, number of authors, number of institutions, number of publications, keywords, and references of 16,934 resveratrol-related papers from 2014-2023 for quantitative and qualitative analysis. The results showed that an average of 1693.4 papers were published per year, with a general upward trend. China had the most publications with 5877. China Medical University was the institution with the largest number of publications and the highest number of citations in the field. The research team was mainly led by Prof. Richard Tristan, and the journal with the highest number of published papers was Molecular. Dietary polyphenols, oxidative stress, and antioxidant and anti-inflammatory effects are the most frequently cited articles. Oxidative stress, apoptosis, expression, and other keywords play an important role in connecting other branches of the field. Our analysis indicates that the integration of nanoparticles with RSV is poised to become a significant trend. RSV markedly inhibits harmful bacteria, fosters the proliferation of beneficial bacteria, and enhances the diversity of the intestinal flora, thereby preventing intestinal flora dysbiosis. Additionally, RSV exhibits both antibacterial and antiviral properties. It also promotes osteogenesis and serves a neuroprotective function in models of Alzheimer's disease. The potential applications of RSV in medicine and healthcare are vast. A future research challenge lies in modifying its structure to develop RSV derivatives with superior biological activity and bioavailability. In the coming years, innovative pharmaceutical formulations of RSV, including oral, injectable, and topical preparations, may be developed to enhance its bioavailability and therapeutic efficacy.

Harnessing spectrophotometry resolution power for determining ternary mixture for respiratory disorders treatment in their pharmaceutical formulation.

A ternary mixture incorporating Hydroxyzine hydrochloride (HYX), Ephedrine hydrochloride (EPH) and Theophylline (THP) frequently prescribed for the treatment of respiratory diseases. Herein, two spectrophotometric methods are designated and applied to resolve these three components in their mixture. Method A is ratio-subtraction combined with derivative spectrophotometry, where THP can be determined directly at its λmax 271 nm (neither HYX or EPH interfere), then for determination of HYX and EPH, the ternary mixture was divided by 22 μg/mL of THP and after subtraction of the plateau region, HYX can be determined directly at its λmax 234.2 nm (absence of EPH intervention). Finally, the third derivative (3D) spectrophotometric approach was utilized to estimate EPH by detecting the peak amplitude at 222 nm with Δλ = 4 and a scaling factor 100. Principal Component Regression (PCR) and Partial Least Squares (PLS), two multivariate calibration approaches, were applied effectively in Method B. This method effectively quantified the mixture under investigation by using the absorption spectra obtained from suitable solutions of the three components in the 210-230 nm region. The calibration models were evaluated using cross-validation with PCR and PLS, producing statistical characteristics that demonstrate the effectiveness of the calibration models. Synthetic and pharmaceutical preparations were also used to conduct external validation. In pharmaceutical formulation, these methods were successfully applied to analyze HYX, EPH, and THP without overlap from formulation's excipients. Moreover, the study's findings were statistically contrasted with those of earlier reported HPLC method. Appraisal approaches were used to determine whether the new spectrophotometric methods had an adverse environmental impact involving the Green Analytical Procedure Index (GAPI) and the AGREE (Analytical Greenness). These evaluations delivered information about the methods' eco-friendliness and sustainability, proving that they are in line with ecologically attributed practices. Furthermore, the Blue Applicability Grade Index (BAGI) was utilized to identify and verify the feasibility and practicality of the suggested approaches.

Spectrophotometric determination of salbutamol sulphate in bulk and in pharmaceutical formulations

طُوّرتْ طريقة لونية جديدة بسيطة وحسّاسة لتعيين تركيز السالبيتمول في المادة النقية وفي بعض المستحضرات الصيدلانية إنّ تعتمد الطريقةَ على الحصول على لون لصبغة الازو الصفراء عند طول موجي 447 نانومتر والمتكونة مِن ْازدواج السالبيتمول مع ملح الديازونيوم ل 2و4- ثنائي كلورو أنيلين, قانون بير وجد مطاعاَ في مدى تركيزَ20-2.5 ملغم/لتر مع ظهور مدى لقيم الامتصاصية المولارية بين(4000-7265) لتر/مول.سم.وقد قدرت الظروف المثلى للتفاعل وكذلك العوامل التحليلية الأخرى.

Multivariate Calibration Techniques Using UV Spectrophotometry for Quantifying Ticagrelor in Pharmaceutical Formulations

Multivariate Calibration Techniques Using UV Spectrophotometry for Quantifying Ticagrelor in Pharmaceutical Formulations

Smartphone based TLC approach versus conventional densitometric measurement for the simultaneous determination of donepezil and memantine, content uniformity testing along with greenness and whiteness assessment

Thin layer chromatography (TLC) is a straightforward and economical technique that plays a major role in analytical field. Introducing the amenities of smartphones as accessible alternative detectors to TLC separation methods elaborates the cost-effectiveness of this technique and supports the appropriate assay of various aliphatic compounds after visualization by suitable reagents. Herein, two TLC coupled with smartphone's camera approaches are proposed for the assay of donepezil hydrochloride (DON) and memantine hydrochloride (MEM), a combined medication used in the management of Alzheimer's disease. Separation was achieved using a developing system of ethyl acetate, methanol, toluene, and ammonia (33%, w/v) in a ratio of 4:1:4:0.2, by volume. The dried plates were scanned at 190 nm for the densitometric assay, then visualized with modified Dragendorff's reagent and photographed by smartphone's camera. The data were integrated by displaying the photos in either ImageJ software or Color-Picker application. The findings produced from the three detection approaches were contrasted over concentration ranges of 1–18 & 4–28 μg/spot for the densitometric method, while the range was 1–20 & 1–30 μg/spot for the ImageJ method and 3–18 & 2–20 μg/spot for the Color-Picker method for DON and MEM, respectively. The methods were suitable for assaying both drugs in their pure form and combined pharmaceutical formulations. Densitometric and ImageJ-based methods were applied to evaluate the dosage forms content uniformity. The developed methods were assessed by three metric tools for greenness and sustainability, namely Green Analytical Procedure Index, Analytical GREEnness Metric Approach, and White Analytical Chemistry.

TiO2 aerogel − A sensing electrode matrix for the sensitive detection of diclofenac sodium

This study developed a new composite matrix containing TiO2 aerogel having mesoporous structure (TiO2AG), bioengineered flagellin (bioF) and chitosan (Ch) deposited on a glassy carbon electrode (GCE), for the detection of diclofenac sodium (DS) in aqueous solutions. It is worth mentioning that TiO2AG mesoporous material was used for the first time as a sensitive matrix for DS detection. The morpho-structural properties of the new electrode materials were assessed by X-ray diffraction (XRD), N2 adsorption–desorption measurements, and scanning electron microscopy (SEM) in conjunction with energy-dispersive X-ray spectroscopy. The electrochemical properties of the new bioF + TiO2AG + Ch/GCE modified electrode were determined by cyclic voltammetry (CV), electrochemical impedance spectroscopy (EIS) and square wave voltammetry (SWV) techniques. The developed modified electrode exhibits a significant electrocatalytic activity for DS electrooxidation process reflected in the acquired performances (detection limit of 17 nM, sensitivity of 0.41 A/M, linear range from 0.15 to 2.5 µM), and presents excellent reproducibility, repeatability, and stability. The practical use of the new developed electrode was estimated by quantifying DS in pharmaceutical formulations (recovery mean of 100.66 % for DS, with a relative standard deviation of 0.39 %) and wastewater samples (relative error of 3.15 % and a relative standard deviation of 0.393 when compared to the LC-MS standard technique).

Physical–Chemical and Thermal Properties of Clays from Porto Santo Island, Portugal

The use of clays for thermal treatments and cosmetic purposes continues to be a worldwide practice, whether through the preservation of native cultural traditions, pharmaceutical formulations or integrative health and well-being practices. Special clays, such as bentonites, are very common for healing applications due to their high cation exchange capacity (CEC), high specific surface area (SSA) and alkaline pH values and, therefore, are used in multiple therapeutic and dermocosmetic treatments. Numerous bentonitic deposits occur on Porto Santo Island with different chemical weathering degrees. This research evaluates which residual soils have the most suitable characteristics for pelotherapy. The texture of residual soils varies from silt loam to loamy sand and SSA between 39 and 90 m2/g. The pH is alkaline (8.7 to 9.6), electrical conductivity ranges from 242 to 972 µS/cm, and CEC from 50.4 to 86.8 µS/cm. The residual soils have a siliciclastic composition (41.36 to 54.02% SiO2), between 12.52 and 17.65% Al2O3 and between 52 and 82% smectite content, which are montmorillonite and nontronite. Specific heat capacity (0.5–0.9 J/g°C) and cooling kinetics (14.5–19 min) show that one residual soil has the potential to be suitable for pelotherapy according to the literature. Moreover, the residual soils have As, Cd, Co, Cr, Hg, Mn, Ni, Pb, Sb and V concentrations higher than the limits of guidelines for cosmetics and pharmaceutical products.

Editorial du Pr Serigne Omar SARR

Dear readers, Dear authors ! The second publication of your quarterly journal is available on time thanks to the commitment of the peer reviewers, the publisher (Presses Universitaires de Dakar), the scientific and editorial committees and the Secretariat which made it possible to proceed within the planned deadlines and in scientific rigor, the evaluation and publication process. This volume 2, number 3 includes three scientific articles that contribute to the transparent and equitable dissemination of science in open access. These original indexed articles address the identification of the artemether-lumefantrine combination in pharmaceutical forms using mid-infrared spectrometry in Benin and chemometric tools, the evaluation of the antioxidant potential of three plants from Niger (Vernonia amygdalina Del., Tephrosia purpurea (L..), Momordica balsamina (L.) ) and the anti-falciemic, anti-hemolytic properties and acute toxicity of three plants from the Niger Pharmacopoeia (Annona senegalensis Linné. Boscia senegalensis (Pers) Lam. and Ampelocissus africana (Lour) Merr.). We thank the entire editorial team and peer reviewers for their collaboration. To your manuscripts and excellent reading!

Development of a model of a dosage form for a new domestic compound (pyrrolo[3,2-l]acridinone derivative) and studying its cytotoxic activity

Background. Expanding the list of safe and effective medicines are the main directions of development of modern medicine and pharmacy. Acridine derivatives are an interesting object of study due to their proven antitumor effect on leukemia and lymphoma. The mechanism of their antitumor effect is the ability to intercalate DNA, as well as to inhibit topoisomerases and telomerase, initiate ROS-mediated oxidative stress, arrest the cell cycle, and interact with glycoprotein-P.Aim. To develop the composition and technology for obtaining a model pharmaceutical form (PF) for parenteral use of a new compound a pyrrolo [3,2-l] acridinone derivative with antitumor activity.Materials and methods. Substance MOB 265 S (Institute of Technical Chemistry of Ural Branch of Russian Academy of Sciences – Perm Federal Research Center, Ural Branch of Russian Academy of Sciences, Russia), polyvinylpyrrolidone (PVP, Kollidon® 17PF, BASF, Germany), polyoxyl-35-castor oil (Cremophor® ELP, BASF, Germany), macrogol (15) – hydroxystearate (Cremophor® ELP, BASF, Germany), water for injection. Technological (solubilization, dissolution, filtration, lyophilization), analytical (spectrophotometry, potentiometry) and biological (in vitro) methods were used in the experimental work. Cytotoxic activity was determined on cell lines of T-cell lymphoblastic leukemia Jurkat, PC-3 prostate carcinoma, A549 lung carcinoma, colon carcinoma HCT-116, breast adenocarcinoma MCF-7.Results. In the course of experimental studies using various solubilizers, model compositions of a PF based on MOB 265 S were obtained, in which water for injection was used as a solvent. The formation of a clear solution was observed only in the model with PVP, which was characterized by basic pharmaceutical parameters and studied in vitro. The inhibitory concentration causing 50 % cell death on various cell lines was 29.6–65.5 μM.Conclusion. Model of the PF a new domestic compound (pyrrolo [3,2-l] acridinone derivative) in the form of a lyophilisate with a mass ratio of MOB 265 S: PVP – 1:5, as well as a technology for its production in 5 stages. The main quality indicators of the resulting model were selected. The results of cytotoxic activity showed that the composition is effective in all used cell cultures, with maximum cytotoxicity observed in the Jurkat leukemia cell line, which coincides with literature data on the cytotoxic activity of acridine derivatives on leukemia and malignant lymphomas. The new PF is promising for further research as an import substitution, due to the lack of acridinone derivative drugs in Russia.

Development and validation of a stability-indicating HPLC method for assay of tonabersat in pharmaceutical formulations

A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed to assay tonabersat and assess its stability in pharmaceutical formulations. Chromatographic separation was achieved using a Kinetex® C18 column (2.6 µm, 150 x 3 mm, 100 Å) at 50 °C, with a 20 µL injection volume. A linear gradient of acetonitrile in water (5 – 33.5 %) was applied for 1 min, followed by a gradual increase to 100 % over 26 min at a flow rate of 0.5 mL/min. Tonabersat and its degradation products were detected at 275 nm and 210 nm, respectively. The optimized method was used to evaluate the stability of tonabersat in lipid-based pharmaceutical formulations at 5 ± 3 °C, 25 ± 2°C/60 ± 5 % RH, and 40 ± 2 °C/75 ± 5 % RH over 3 months. The method was validated as per ICH guidelines and demonstrated linearity in the range of 5 – 200 µg/mL (R2 = 0.99994) with good accuracy (98.25 – 101.58 % recovery) and precision (% RSD < 2.5 %). The limits of detection and quantitation were 0.8 µg/mL and 5 µg/mL, respectively. Forced degradation studies showed significant degradation on exposure to alkaline (90.33 ± 0.80 %), acidic (70.60 ± 1.57 %), and oxidative stress (33.95 ± 0.69 %) at 70 °C, but no degradation was observed on exposure to thermal or photolytic stress. No chemical degradation was observed in either formulation on storage. Thus, the method was sensitive, specific, and suitable for stability testing of tonabersat in pharmaceutical formulations.

Analysis of binary mixture of oxytetracycline and bromohexine in their combined veterinary formulation by four simple spectrophotometric methods with greenness assessment

Tetracyclines family is considered as the first-line antibiotic drugs for food animals. Formulating bromhexine (BR) with oxytetracycline (OTC) improved the antibacterial activity of OTC, besides it is considered as a mucolytic agent. Four precise, rapid, and simple spectrophotometric methods were successfully developed for resolution of the overlapped spectra of OTC and BR in their pure form and in their pharmaceutical formulation. The proposed methods are absorption correction (AC), dual wavelength (DW), induced dual wavelength (IDW), and spectrum subtraction (SS) spectrophotometric methods. The developed methods were used for the determination of OTC and BR in the ranges of 2–50 µg/mL and 1–30 µg/mL, respectively for all methods. For (AC) and (SS) methods, OTC and BR were determined at 380 nm and 245.6 nm, respectively after spectral resolution steps. While for (DW) method, the absorbance difference between λ (271.8 –287.6 nm) and λ (245.6 –283.2 nm) were used for the determination of OTC and BR, in order. For IDW, it depended on using the absorbance difference between 271.8 nm and 245.6 nm as well as the equality factor (F) calculated for each drug at the selected wavelengths. In all methods, HCl was used as a solvent and they are validated according to ICH guidelines. Several green metric tools have been developed to evaluate the greenness of the analytical methods like National Environmental Methods Index (NEMI), Modified NEMI, Analytical Eco-scale, Green Analytical Procedure Index (GAPI) and Analytical GREEnness calculator (AGREE), and all ensured the low impact of the suggested approaches on health and environment. The proposed methods are highly selective, robust and precise. Additionally they are time and money effective and can be used in any analytical laboratory.

Comprehensive Review of the Latest Investigations of the Health-Enhancing Effects of Selected Properties of Arthrospira and Spirulina Microalgae on Skin.

Arthospira platensis and Spirulina platensis microalgae are a rich source of pro-health metabolites (% d.m.): proteins (50.0-71.3/46.0-63.0), carbohydrates (16.0-20.0/12.0-17.0), fats (0.9-14.2/6.4-14.3), polyphenolic compounds and phenols (7.3-33.2/7.8-44.5 and 4.2/0.3 mg GAE/g), and flavonoids (1.9/0.2 QUE/g) used in pharmaceutical and cosmetic formulations. This review summarises the research on the chemical profile, therapeutic effects in dermatological problems, application of Arthrospira and Spirulina microalgae, and contraindications to their use. The pro-health properties of these microalgae were analysed based on the relevant literature from 2019 to 2024. The antiviral mechanism of microalgal activity involves the inhibition of viral replication and enhancement of immunity. The anti-acne activity is attributed to alkaloids, alkanes, phenols, alkenes, phycocyanins, phthalates, tannins, carboxylic and phthalic acids, saponins, and steroids. The antibacterial activity generally depends on the components and structure of the bacterial cell wall. Their healing effect results from the inhibition of inflammatory and apoptotic processes, reduction of pro-inflammatory cytokines, stimulation of angiogenesis, and proliferation of fibroblasts and keratinocytes. The photoprotective action is regulated by amino acids, phlorotannins, carotenoids, mycosporins, and polyphenols inhibiting the production of tyrosinase, pro-inflammatory cytokines, and free oxygen radicals in fibroblasts and the stimulation of collagen production. Microalgae are promising molecular ingredients in innovative formulations of parapharmaceuticals and cosmetics used in the prophylaxis and therapy of dermatological problems. This review shows the application of spirulina-based commercial skin-care products as well as the safety and contraindications of spirulina use. Furthermore, the main directions for future studies of the pro-health suitability of microalgae exerting multidirectional effects on human skin are presented.

Thermal Compatibility of New ACEI Derivatives with Popular Excipients Used to Produce Solid Pharmaceutical Formulations.

Background/Objectives: Increasing drugs' stability and adequately protecting them against degradation will ensure a decrease in their price and broader availability of pharmaceutical substances. This is of great importance, especially for drugs used to treat the most common diseases in the population, such as hypertension. The study examined two newly synthesized substances from the angiotensin I-converting enzyme inhibitor (ACEI) group as potential drugs. ACEIs are among the leading drugs used in the treatment of hypertension in the world. The chemical modifications of the tested substances applied concerned the places most susceptible to degradation. The presented work analyzed the compatibility of new derivatives with selected excipients used in pharmacy. Methods: Thermogravimetric (TGA) and differential thermal analyses (c-DTA) were used as the main methods. In addition, non-thermal methods such as colorimetry analysis, Fourier-transform infrared (FTIR) and UV spectroscopy were used. Results: Based on the conducted studies, it can be concluded that the incompatibility of IND-1 with glucose anhydrous and lactose monohydrate occurs only when the mixture is stored at higher temperatures. For the remaining IND-1 and IND-2 mixtures with excipients, compatibility was demonstrated. Conclusions: The obtained results confirmed the usefulness of the applied thermal analyses (TGA and c-DTA) for assessing the compatibility of the tested potential drugs with excipients. However, in the case of incompatibility reactions of substances occurring under the influence of elevated temperatures, such as the Maillard reaction, it is necessary to use non-thermal methods to obtain the right result.

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 to 800 ng/mL, with detection and quantification limits of 12.6 ng/mL and 38 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.

Simultaneous estimation of prasugrel and aspirin in bulk drugs by chemometric methods

A UV–Vis spectrophotometric method enhanced by chemometric techniques, specifically Principal Component Regression (PCR) and Partial Least Squares (PLS) regression, was developed and validated for the simultaneous quantification of prasugrel (PRA) and aspirin (ASP) in bulk drugs and pharmaceutical formulations. The method demonstrated high accuracy, precision, and robustness, achieving mean recoveries of 100.63% for PRA and 100.08% for ASP with relative standard deviations (RSD) below 3%. Both PCR and PLS models showed excellent predictive capabilities, with RMSEP values of 0.45–0.48 for PRA and 0.78–1.13 for ASP, indicating the models’ reliability. In line with green and white chemistry principles, the method minimizes environmental impact by reducing solvent consumption and waste generation compared to traditional chromatographic methods. The Analytical Eco-Scale score was 84, reflecting excellent compliance with green chemistry standards. The method’s simplicity, low energy consumption, and reduced chemical waste further support its alignment with sustainability goals. However, acetonitrile, a hazardous solvent, was still used in small quantities, and solvent recycling was not implemented, slightly affecting the eco-score. To evaluate the method’s greenness, the RGB12 algorithm was applied, achieving a high score of 94.4%, with the majority of parameters related to reagent consumption, waste production, energy efficiency, and safety scoring optimally. The method’s safety, cost-effectiveness, and minimal environmental footprint make it suitable for routine pharmaceutical analysis, particularly in quality control environments where resource efficiency and sustainability are prioritized. Thus, the developed method offers a sustainable, efficient, and environmentally friendly solution for the simultaneous analysis of prasugrel and aspirin in pharmaceutical formulations, making it a valuable tool for routine analysis in the pharmaceutical industry.

A Highly Sensitive Inclusion Complex Based Spectrofluorimetric Method for the Determination of Certain Sodium Glucose Cotransporter-2 Inhibitors: Greenness Assessment and Application to Different Biological Fluids.

This study introduces a remarkably simple, green, and highly sensitive inclusion complex based spectrofluorimetric method for analyzing two sodium glucose cotransporter-2 (SGLT2) inhibitors: empagliflozin (EGF) and dapagliflozin (DGF). The method utilizes beta-cyclodextrin (β-CD) complexation to enhance the native fluorescence of EGF and DGF in aqueous solutions, resulting in 11.0-fold and 9.0-fold intensity increases, respectively. Fluorescence measurements were conducted at 301 nm emission following 230 nm excitation for both drugs. The method demonstrates excellent linearity (0.9994 for EGF and 0.9993 for DGF) over concentration ranges of 5.0-250.0 ng/mL and 10.0-300.0 ng/mL, with low detection limits of 1.05 and 1.38 ng/mL for EGF and DGF, respectively. The method's versatility was validated through successful application in pharmaceutical formulations, content uniformity testing, and biological fluids. This eco-friendly approach primarily uses water as a solvent and requires minimal reagents. The method's environmental impact was comprehensively evaluated using the analytical eco-scale, green analytical procedure index (GAPI), and analytical greenness metric (AGREE).

The Creation and Validation of a New High-Performance Liquid Chromatography Method for Analyzing Pyridostigmine Bromide and its Degradation Products in a Pharmaceutical Formulation

The Creation and Validation of a New High-Performance Liquid Chromatography Method for Analyzing Pyridostigmine Bromide and its Degradation Products in a Pharmaceutical Formulation

A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation

Valproic acid and its derivatives are common drugs used in the treatment of epilepsy, a result of CNS disorders. Because the molecular structure of valproic acid, as a fatty acid, does not contain any chromophore groups, its peak response demanded special conditions to be detected in HPLC, ensuring the best precision results. Still, the current approach illustrates simple, validated procedures for conduction. The conducted chromatographic system consists of the BDS Hypersil C8, 150 × 4.6 mm, 5 µm column using a mobile phase of acetonitrile: phosphate buffer (4:6) at a detection wavelength of 215 nm at room temperature. A full method validation study was conducted and approved to ensure precise, repeatable, and accurate results by implementing system suitability parameters. In microbiological terms, a suitability test is used to validate microbiological testing methods, ensuring their efficacy despite potential interference from antimicrobial properties in the tested materials. The HPLC-UV developed and validated analytical method was evaluated, and it was found to be sensitive for use in the detection of low concentrations of methylparaben, propylparaben, and valproate with an optimum run time of six minutes. limit of detection (LODs) were statistically estimated and found to be 2.27 µg/mL, 39.77 ng/mL, and 1.84 µg/mL for methylparaben, propylparaben, and valproate, respectively. Additionally, the method demonstrated a high recovery of methylparaben, propylparaben, and valproate with an excellent closed-accuracy range (98.84% - 101.34%). An excellent regression coefficient (r) of 0.99924, 0.99998, and 0.99997 for methylparaben, valproate, and propylparaben, respectively, was achieved. Assay determination of various pharmaceutical dosage forms in the local market was implemented, yielding admirable results.