Pharmaceutical Dosage Forms Research Articles

DEVELOPMENT AND VALIDATION OF THE HS-GC-FID METHOD FOR THE QUANTIFICATION OF RESIDUAL SOLVENTS IN DESLORATADINE

Testing for residual solvents is a crucial component of both reference material certification and pharmaceutical quality control. Developing and validating a head space-gas chromatography method for measuring residual solvents in desloratadine in pharmaceutical dosage forms was the aim of the current investigation. To create desloratadine, an active ingredient in pharmaceuticals, the pharmaceutical industry commonly uses organic solvents such as methanol, diethyl ether, dichloromethane, and tetrahydrofuran. A novel technique for measuring residual solvents in desloratadine was created using a flame ionization detector and headspace gas chromatography. HP1 Column (30m×0.53mm, 1.8µm), intake port maintained at 250°C, detector temperature 260°C, oven temperature 190°C, and injection volume 1µl with 1:50 split ratio utilizing nitrogen as a carrier gas at a flow rate of 1ml/min were the optimum chromatographic conditions. Using criteria from the International Conference on Harmonization, the method's linearity, range, detection limit, quantitation limit, accuracy, precision, specificity, system appropriateness, and robustness were all validated. It was determined that the idea was appropriate for determining four distinct residual solvents. The approach is particular, linear, exact, accurate, and sensitive, according to validation data, where recoveries varied from 90 to 110 percent. This thoroughly tested technique has been used to identify any remaining solvents in actual desloratadine bulk samples.

Pharmaceutical Polygon Fingerprinting Matrix System: A Potential Tool for Pharmaceutical Quality Control

Background: We describe a new discriminatory system for evaluating the quality of pharmaceuticals, the Pharmaceutical Polygon Fingerprint Matrix system (PharmP-FM). PharmP-FM uses both qualitative and quantitative fingerprinting techniques to assess the quality of pharmaceutical formulations and dosage forms, the system expands on the Expert System for Drug Development, which was initially created to evaluate the suitability of powder for direct compression. PharmP-FM creates a graphical representation of the product’s pharmaceutical quality using a set of input parameters. The performance index (PI), normalized parameter index (NPI), and formulation index (FI) are among the system's output parameters. The objective of this study was to evaluate the performance of PharmP-FM by examining its ability to identify variations in pharmaceutical quality across products. Methodology: We examined the application of PharmP-FM in assessing batch-to-batch variability of weight-loss supplement capsules and the quality of multisource brand products of levothyroxine tablets. Results: PharmP-FM exhibits potential promise as a pharmaceutical quality assessment tool. Its user-friendly nature and adaptability to different formulations and dosage forms make it a versatile discriminatory system. Additionally, PharmP-FM is an open-ended and scalable system that can incorporate additional parameters and accommodate products of varying complexities. Conclusion: This study supports the potential of PharmP-FM as a tool for pharmaceutical quality assessment.

Analytical method for determination of Lenvatinib in pharmaceutical and bulk dosage form by using RP-HPLC Method

Analytical method for determination of Lenvatinib in pharmaceutical and bulk dosage form by using RP-HPLC Method

High-Throughput Optimisation for 3D Raman Chemical Imaging of Pharmaceutical Solid Oral Dosage Forms

Chemical imaging of pharmaceutical solid oral dosage forms is a key technique for quality assurance and issue diagnosis. This technique can be further enhanced using 3D chemical imaging via serial...

Method Development and Validation of Lorlatinib by RP-HPLC.

A simple, Accurate, precise method was developed for the estimation of the Lorlatinib in API form and Marketed pharmaceutical dosage form by RP-HPLC. Chromatogram was run through Hypersil C18 (4.6mm×150mm, 5µm) Particle size Column and Mobile phase containing Methanol and Water taken in the ratio of 25: 75% v/v was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 38ºC. Optimized wavelength selected was 310 nm. Retention times of Lorlatinib were found to be 3.513 minutes respectively. The %RSD for the Repeatability and Intermediate Precision of the Lorlatinib were found to be within limits. %Recovery was obtained 98.96% and it was found to be within the limits for Lorlatinib respectively. The LOD, LOQ values obtained from regression equations of Lorlatinib were 0.332µg/ml and 1.0078 µg/ml respectively. Regression equation of Lorlatinib was found to be y = 39948x + 16821 respectively. The Retention times was decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

A recent review of the utilization of 3D printing in the development and manufacturing of pharmaceutical dosage forms

A recent review of the utilization of 3D printing in the development and manufacturing of pharmaceutical dosage forms

GREEN METHOD FOR THE SPECTROPHOTOMETRIC DETERMINATION OF PHENYLEPHRINE AND TERBUTALINE PHARMACEUTICAL FORMULATIONS

Determination and evaluation active substances in chemical settings is extremely difficult, linked to chemical waste in water sewage, and may eventually have an influence on public health. As a result, efforts are being made globally to find other, perhaps less hazardous ways. Hereby, we aimed to determine two pharmaceutical products for the detection of phenylephrine hydrochloride and terbutaline sulphate using green chemistry. The procedure involves oxidizing phenylephrine hydrochloride and terbutaline sulphate using potassium permanganate as an oxidant and decolorizing the surplus of potassium permanganate in the reaction with Nile blue dye. The results confirmed that this method has provided easy and precise evaluation of phenylephrine hydrochloride and terbutaline sulphate at concentrations ranging from (0.4-4.5) µg /ml, with molar absorption capacity of (6.9x104 ) l‧mol-1 ‧cm -1 for phenylephrine hydrochloride and (1.44×105 ) l‧mol-1 ‧cm -1 for terbutaline sulphate. The methodologies have precisely determined the pharmaceutical dosage forms of the tested drugs, agreeing with previously tested and stated values and standard compounds.

Cefoperazone Sodium Content Assay in Pharmaceutical Formulations: Development and Validation of High‐Performance Liquid Chromatographic Method

A precise and sensitive RP‐HPLC method is used to assay pharmaceutical dosage forms and bulk drugs for cefoperazone sodium (CPZ). The mobile phase for cefoperazone separation is a combination of acetonitrile and 0.05 M ammonium acetate buffer (pH 4.5) in a 70 : 30 (v/v) ratio. This was separated by using a Waters XTerra RP‐18 column (5 µm 250 × 4.6 mm internal diameter) that was working at a flow rate of 1.0 ml/min. Photodiode array detectors are able to set it at 235 nm. Based on the percentage recovery, the process produced a notable linear response ranging from 0.2 to 20 µg/ml, with a significant precision of 0.27 to 0.67% and an excellent accuracy of 99.90 to 100.02%. Because of its outstanding sensitivity, accuracy, precision, and ease of use, we highly suggest using the reversed‐phase HPLC method. Therefore, a laboratory could utilize this method for routine quality control analysis.

Luminescent and time-resolved determination of gemifloxacin mesylate in pharmaceutical formulations and spiked blood plasma samples using a lanthanide complex as a probe.

A novel luminescence-based analytical methodology was established employing a europium(III) complex with 3-allyl-2-hydroxybenzohydrazide (HAZ) as the coordinating ligand for the quantification of gemifloxacin mesylate (GMF) in pharmaceutical preparations and human plasma samples spiked with the compound. The stoichiometry of the europium complex with HAZ was determined via the Job plot and exhibited a metal-to-ligand ratio of 1 : 2. The analytical procedure relies on a rapid and significant enhancement of luminescence by the Eu(AZ)2 complex when it interacts with gemifloxacin mesylate, which allowed for the rapid detection of 96 samples within approximately 2 minutes. The thermodynamic parameters of the complexation of GMF with Eu(AZ)2 were evaluated and showed that the complexation of GMF was spontaneous with a negative ΔG. The binding constant K was 4.27 × 105 L mol-1 and DFT calculations supported GMF binding and the formation of Eu(AZ)2-GMF without further ligand exchange. The calibration graph for the luminescence quantitation of GMF was linear over a wide concentration range of 0.11-16 μg mL-1 (2.26 × 10-7 to 3.30 × 10-5 mol L-1), with a limit of quantification (LOQ) of 110 ng mL-1 (230 nmol L-1) and a detection limit (LOD) of 40 ng mL-1 (82 nmol L-1). The proposed method showed good accuracy with an average recovery of 99% with relative standard deviations of less than 5% in spiking experiments, even in complex pharmaceutical dosage forms such as tablets and in human blood plasma. Herein, the ability of the suppression of the luminescence background by using the long lag times of the lanthanide probe in a time-resolved detection scheme provided reliable and precise results, which suggests its potential for use in further real or patient samples.

Stability Indicating UPLC Method Development and Validation for the Quantitative Estimation of Pazopanib in Pure form and Marketed Pharmaceutical Dosage form.

An analytical, accurate, precise, specific, efficient and simple Ultra-Performance Liquid Chromatography method has been developed and validated for the determination of Pazopanib in bulk and was applied on marketed Pharmaceutical Dosage form. The mobile phase used for the chromatographic runs consisted of 0.1% OPA Buffer and Acetonitrile in the ratio of 30:70% v/v. The separation was achieved on a BHEL UPLC column using isocratic mode. Pazopanib Drug peak were well separated and were detected by a PDA detector at 256 nm. The developed method was linear at the concentration range 6-14 μg/ml for Pazopanib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The LOD and LOQ for the Pazopanib were found to be 0.5853 µg/ml and 1.7738µg/ml respectively. The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Pazopanib in bulk and marketed pharmaceutical dosage form dosage form.

Development and Validation of new RP-HPLC Method for the Simultaneous Estimation of Elbasvir and Grazoprevir in Combined Pharmaceutical Dosage Form

A reliable and exact technique was formulated for concurrently determining Elbasvir and Grazoprevir in tablet dosage forms. Chromatogram was developed by running a sample through Zodiac C18 column (4.6 x 150 mm, 5 µm) with the mobile phase containing Orthophosphoric acid (0.1%) and Acetonitrile in the ratio 50:50 v/v. The solution was pumped through the column at a flow rate of 1 ml/min, while maintaining the column temperature at 30°C. The optimized wavelength selected was 260 nm. The retention times for Elbasvir and Grazoprevir were determined to be 2.32 min and 3.30 min, respectively. The percentage recovery was found to be 100.16% for Elbasvir and 99.49% for Grazoprevir. The LOD and LOQ values obtained from the regression equations for Elbasvir were 0.30 mg/ml and 0.92 mg/ml, and for Grazoprevir were 0.28 mg/ml and 0.86 mg/ml, respectively. The regression equation for Elbasvir was found to be y = 2282.5x + 2407.2, and for Grazoprevir, it was y = 2366.5x + 7740.4. In conclusion, the developed method proved to be simple and economical, demonstrating successful application for the simultaneous estimation of both Elbasvir and Grazoprevir in bulk and combined tablet formulations. Keywords: Elbasvir, Grazoprevir, RP­HPLC, Validation, Simultaneous estimation

Development and validation of an HPLC method for the simultaneous estimation of salbutamol, theophylline and ambroxol in tablet dosage form

A simple, accurate and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of Salbutamol, Theophylline and Ambroxol in pharmaceutical formulations. The chromatographic separation was achieved on a Inertsil ODS-3V (250 × 4.6 mm, 5μ) column using a mobile phase consisting of phosphate buffer (pH 3.0): acetonitrile in the ratio of 55:45 v/v at a flow rate of 1 mL/min. Detection was carried out at 225 nm. The retention times for Salbutamol, Theophylline and Ambroxol were found to be 2.317, 3.808 and 5.863 min respectively. The proposed method was validated as per the ICH guidelines and was found to be linear in the concentration range of 0.5-3.0 μg/mL, 25-150 μg/mL and 7.5-45 μg/mL for Salbutamol, Theophylline and Ambroxol respectively with correlation coefficients greater than 0.999. The developed method was found to be precise, accurate, robust and specific. Forced degradation studies proved the stability-indicating capability of the developed HPLC method. The developed method can be successfully applied for the routine analysis of Salbutamol, Theophylline and Ambroxol in pharmaceutical dosage forms.

Development and Validation of HPLC Method for Simultaneous Estimation of Minoxidil and Finasteride in Topical Solution

A simple, precise, rapid, accurate HPLC method has been developed and validated for the simultaneous determination of Minoxidil and Finasteride in pharmaceutical dosage form. The chromatographic separation was achieved on ODS C18 column (250mm*4.6mm,5 micrometer particle size) using a mobile phase comprising Buffer(7.0PH); ACN 80:20% v/v. The flow rate was 1ml/min and eluents were detected by UV detector at 210 nm. Retention times were found to be 2.967 min and 5.750 min Finasteride and Minoxidil respectively. The calibration curve was linear over the range of 20-80 microgram/ml of Minoxidil and 0.5 -1.6 microgram/ml of Finasteride. The developed method was successfully applied for determination of the two drugs from its pharmaceutical formulation. The excipients in the formulation do not pose any hindrance in determination of two drugs. The proposed method is suitable for routine quality control analysis

Unraveling the Multifaceted Roles of Extracellular Vesicles: Insights into Biology, Pharmacology, and Pharmaceutical Applications for Drug Delivery.

Extracellular vesicles (EVs) are nanoparticles released from various cell types that have emerged as powerful new therapeutic option for a variety of diseases. EVs are involved in the transmission of biological signals between cells and in the regulation of a variety of biological processes, highlighting them as potential novel targets/platforms for therapeutics intervention and/or delivery. Therefore, it is necessary to investigate new aspects of EVs' biogenesis, biodistribution, metabolism, and excretion as well as safety/compatibility of both unmodified and engineered EVs upon administration in different pharmaceutical dosage forms and delivery systems. In this review, we summarize the current knowledge of essential physiological and pathological roles of EVs in different organs and organ systems. We provide an overview regarding application of EVs as therapeutic targets, therapeutics, and drug delivery platforms. We also explore various approaches implemented over the years to improve the dosage of specific EV products for different administration routes.

Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form

Objective: The study’s goal is to develop a highly appropriate, fast, precise, and validated reverse-phase high-performance liquid chromatography (RP-HPLC) approach that indicates stability for the estimation of tepotinib in pharmaceutical dosage form and bulk, in accordance with ICH recommendations. Method: The components were separated by chromatography using a Phenomenex Kinetex XB-C18 (150×4.6 mm, 5μ) column. The absorbance was measured at 272 nm, and the flow rate was 1.0 mL̸min. The International Council for Harmonisation (ICH) states that checks were made for linearity, precision, accuracy, system appropriateness, specificity, and protocol robustness. Results: Tepotinib was shown to have a retention period of 3.4 minutes. The results showed that the linearity ranged from 5 to 25 μg/mL (r2 = 0.9993), and the percentage mean recoveries for tepotinib’s accuracy and precision fell within the range of (%RSD˂ 2). It was discovered that the Limit of Detection (LoD), and Limit of Quantitation (LoQ) were, respectively, 0.429 and 1.3 μg/mL.

Characterization of Forced Degradation Products of Netarsudil: Optimization and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Process-Related Impurities.

The aim of this study is to examine resolution, identification, and characterization of forced degradation products of netarsudil by liquid chromatography-tandem mass spectrometry by validating a simple and sensitive high-performance liquid chromatography method for the resolution, identification, and quantification of two process-related impurities in netarsudil. Chromatographic separation was accomplished on a ZORBAX Eclipse XDB C18 (250 x 4.6 mm; 5 µ id) column at room temperature as the stationary phase and 257 nm as the detector wavelength with the mobile phase consisting of acetonitrile, methanol, and pH 4.6 phosphate buffer in 45:35:20 (v/v) at 1.0 mL/min flow rate in isocratic elution. The method reported very sensitive detection limits of 0.008 µg/mL for impurity 1 and 0.003 µg/mL for impurity 1. The method produces a calibration curve linear in the concentration level of 25-200 for netarsudil and 0.025-0.2 µg/mL for impurities. The proposed method gives acceptable results for other validation parameters such as accuracy, precision, ruggedness, and robustness. The drug was subjected to various stress conditions such as acid, base, peroxide, and thermal and ultraviolet light to investigate the stability-indicating ability of the method. Considerable degradation was observed in stress studies, and the degradation products were well resolved from process-related impurities. The characterization of degradation products was performed on the basis of collision-induced dissociation mass spectral data, and the possible structures of the six degradation compounds of netarsudil were proposed. The outcomes of other validation studies were likewise satisfactory and proven adequate for the regular analysis of netarsudil and its process-related impurities in bulk drug and pharmaceutical dosage forms and can also be applied for the evaluation of the stress degradation mechanism of netarsudil.

Stability Indicating Reverse Phase Ultra Performance Liquid Chromatography Method Development and Validation for Amiloride and Hydrochlorothiazide Tablet in the Presence of Degradation Products and Application to Green Analytical Principles

Amiloride (AML) and hydrochlorothiazide (HCTZ) combination is used alone or with other medicines to treat high blood pressure (hypertension). The present article provides the development and validation of an reverse phase ultra performance liquid chromatography (RP-UPLC) approach for the quantification of AML, HCTZ, and related impurities in pharmaceutical dosage forms. The analytical column used for the separation of impurities is the Waters X bridge C18 3.5 μm (50 mm X 4.6 mm). Used 0.1% formic acid and ethanol as MP in an isocratic mode with 0.3 mL/min as flow rate and 3 μL as injection volume, at 254 nm as detection in UV and 12 minutes as total run time. The samples were prepared specifically to undergo forced degradation, which involved subjecting them to hydrolysis, oxidation, thermal, and photolytic conditions. The technique underwent validation by the principles set forth by the ICH Q2 guidelines. The validation confirmed that the method possesses specificity, linearity, ruggedness, robustness and accuracy. The methodology employed exhibited a linear relationship extending from 10 to 150% for all impurities. The recovery analysis was conducted throughout a range of concentrations, starting from 10 to 150% concentration. The average recovery value was determined to be within acceptable limits. The evidence of degradation and the findings of the verified study suggest that the nature of the subject under investigation is stable. Hence, this approach might be employed within the domains of pharmaceutical research and development and quality control departments. Green analytical chemistry tools are used to assess the method’s greenness and calculated using GAPI, AGREE and ecological-scale and found excellent green of >75%.

Isolation of Gum from Tamarind and Fenugreek Plants and Its Evaluation as Pharmaceutical Excipients

In contemporary pharmaceutical dosage forms, a variety of auxiliary substances are combined with active compounds to aid in production and achieve the intended effects of the active components. Plant gum is a widely recognized polysaccharide within the pharmaceutical industry, performing an array of functions including stabilizing, disintegrating, suspending, emulsifying, and gelling. Naturally occurring gum is preferred over commercially produced gum due to its affordability, emollient properties, non-irritating nature, natural composition, and lack of toxicity. The costly nature, hazardous properties, contribution to environmental contamination during production, reliance on non-renewable resources, potential adverse effects, and low patient adherence are all drawbacks of synthetic polymers. Gum exhibits considerable potential as an innovative drug delivery system (NDDS) in conjunction with a variety of pharmacological formulations. The advancements achieved in the application of natural polysaccharides, mucilages, and pectins within the domain of medicinal sciences are examined in this research article.

Orally disintegrating tablets: mechanisms, preparation methods, problems and achievements

The oral route of drug administration is considered one of the preferred delivery methods. In recent years, orally disintegrating tablets (ODTs) have become convenient pharmaceutical dosage forms, especially for specific patient populations such as pediatric, geriatric, and psychiatric patients with dysphagia. Rapid disintegration and increased bioavailability are some of the essential characteristics of ODTs that make them superior to other traditional pharmaceutical dosage forms. Orally disintegrating tablets are pills that disintegrate within a few seconds after being placed in the oral cavity. This review describes the mechanisms of drug release from ODTs, manufacturing challenges, and advancements in orally disintegrating tablet technologies.

MOTHERS KNOWLEDGE TOWARDS WOUND CARE IN THE GREATER BANDUNG AREA

Objective: Proper wound care is essential to prevent complications and worsening of the injured patient. Everyone in the family needs to possess wound care knowledge, especially the mother, who plays a role in making decisions about health care and family health behaviors. This study aims to evaluate mothers' knowledge towards wound care in the Greater Bandung Area.
 Methods: This cross-sectional study involved 100 participants with varied backgrounds and had met the inclusion criteria. The study was conducted using questionnaires distributed online to the mother community living in the Greater Bandung Area, West Java, then data processing and analysis were carried out.
 Results: The results showed that mothers in the Greater Bandung Area had a good level of knowledge (27%), average (52%), and less (21%). In addition, plasters with wound care solutions were still the mothers' main choice in wound care. Nevertheless, there are many choices of pharmaceutical dosage forms for wound care that have been developed today to optimize the wound healing process.
 Conclusion: Most of the mothers already have an average level of knowledge to good. However, there are still quite a lot of mothers who have a lack of knowledge related to wound care. Therefore, educational programs must be developed to raise awareness about wound care and management, as well as knowledge about pharmaceutical dosage forms for wound care.