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15 articles for “ICH guidelines”
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RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations
Abstract: RP-HPLC technique formulated for the numerical assessment of Metoclopramide Hydrochloride in tablet formulation has been confirmed for reliability. A C18 column facilitated the chromatographic separation using a mobile phase comprising 60:40 (v/v) potassium dihydrogen phosphate buffer: meth anol mixture. Such method was used to detect, where the retained time was 6.78 minutes and Metoclo pramide Hydrochloride produced a clear peaked at 273 nm. Results were in agreement with ICH Q2 …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 2, 2025 · pp. 07–15 Read article
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A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances
Abstract: Ensuring the safety, efficacy, and quality of pharmaceutical goods is essential in the Indian pharmaceutical market, which is a global centre for generic drugs. Stability studies and impurity profiling are two fundamental activities that ensure this quality during the whole lifespan of a medicine. The effect of environmental variables such as temperature, humidity, and light on the quality of a drug substance over time is demonstrated by stability studies. The …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 3, 2025 · pp. 81–88 Read article
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A Comprehensive Exploration of Method Validation and Development in Pharmaceutical Analysis: Focus on Vortioxetine Analysis
Abstract: The pharmaceutical industry relies on rigorous method validation to ensure the accuracy, precision, and reliability of analytical techniques employed in drug testing and quality control. This comprehensive exploration delves into the validation parameters and guidelines essential for method validation, emphasizing accuracy, precision, linearity, detection and quantitation limits, specificity, range, robustness, and ruggedness. Validation plays a pivotal role in guaranteeing high-quality products, adhering to good manufacturing practices (GMP), and optimizing manufacturing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 46–52 Read article
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Strategies for the Development and Optimization of Orally Disintegrating Tablets (ODTs) to Improve Bioavailability and Patient Compliance
Abstract: Background: Pharmaceutical scientists have developed Orally Disintegrating Tablets (ODTs) to advance patient drug acceptance and biological system availability through simplified medi-cation delivery especially for children and senior citizens and people who cannot swallow pills regularly. The oral disintegrating tablets dissolve in the mouth within thirty seconds or less (USP 701) while needing no additional liquid thus making them suitable for both emergency treatments. Objective: The research examines ODT development strategies …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 13, Issue 2, 2026 Read article
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Development and Characterization of a Solid Dispersion of an Anti-Diabetic Drug Using Pectin as a Natural Polymer
Abstract: Aim: The current study sought to improve the solubility and oral bioavailability of gliclazide by creating solid dispersions and oral dispersible tablets (ODTs) with enhanced physicochemical characteristics and maintained antidiabetic action. Methods: Preformulation studies were conducted to evaluate the physicochemical properties of gliclazide, including physical appearance, melting point, solubility, and partition coefficient. Solid dispersions were prepared using hydrophilic carriers-pectin and PVP K30, and subsequently characterized by Fourier Transform Infrared Spectroscopy …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 17, Issue 2, 2026 Read article
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Simultaneous Determination And Stability Indicating Method For Telmisartan, Metoprolol Succinate And Cilnidipine In Tablet Dosage Form.
Abstract: There are several medicinal agents available for antihypertensive activity. Telmisartan, metoprolol and cilnidipine are among them. Quantitative and qualitative analysis plays a pivotal role in safeguarding patients. Here, the estimation of these drugs was performed by using the chromatographic technique RP-HPLC. It was conducted with Phosphate buffer (pH 3.5 ± 0.01): Methanol (50:50 v/v) mobile phase. The system was operated at 1 ml/min. Drug volume to the system was 20μl. …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 11, Issue 1, 2024 · pp. 32–38 Read article
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Formulation and development of Lamivudine Nanoemulsion by using Emulsifying Polymers and It’s Evaluation
Abstract: Nanoemulsion is a novel approach to medicine delivery that helps to increase the bioavailability of drugs that aren’t particularly soluble in water. In this research work, nanoemulsion of Lamivudine was formulated by using polymers such as SPAN 80, TWEEN 80 and Whey protein concentrate with the help of Ultrasonication technology. The formulation was optimized. It was evaluated by assessing pH, viscosity, turbidity, in vitro franz diffusion study, particle size distribution, …
Published in Journal of Polymer & Composites · Vol. 12, Issue 6, 2024 · pp. 22–35 Read article
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HPTLC Method Development and Validation for Rabeprazole Sodium in Pharmaceutical Formulation
Abstract: Background: The most common medication for acid related disorders stands as Proton pump inhibitor (PPI) Rabeprazole Sodium. The pharmaceutical formulations require essential quality control of Rabeprazole Sodium through reliable analytical methods to maintain reliability. HPTLC provides a cost-effective rapid method for drug quantification compared to conventional HPLC methods so how HPTLC stands as an appropriate method for drug determination. Objective: The emphasis of this research project involves developing and validating …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 18–24 Read article
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Bioanalytical Method Development and Validation for the Estimation of Levothyroxine in Human K₃EDTA Plasma by Using UPLC-MS/MS
Abstract: A rapid, sensitive, and highly selective UPLC-MS/MS method was developed and validated for the quantitative estimation of Levothyroxine in human plasma using Levothyroxine-D₃ as the internal standard (IS). Chromatographic separation was achieved on a Gemini NX-C18 column (50 × 3.0 mm, 3 µm) with a mobile phase consisting of acetonitrile and water (70:30, v/v) containing 0.015% formic acid at a flow rate of 0.5 mL/min. The total run time was …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 32–46 Read article
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Data Integrity Best Practices in Pharmaceutical Quality Assurance: A Thorough Review
Abstract: Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 22–30 Read article
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Development and validation of a method for simulataneous determination of tenovifir disoproxil fumarate emtriculabine and isonized in bulk and pharmaceutical dosage form using RP-HPLC with relevance to toxicological aspects
Abstract: Hence, proposed analytical methods are simple, novel, economical, rapid, sensitive, reproducible and accurate for the Simultaneous estimation of Tenofovir Disoproxil Fumarate, Emtricitabine and Isoniazid in Bulk and Phamaceutical dosage form by using RP- HPLC. This Method gives reliable assay results with short analysis time using mobile phase of Acetonitrile : 0.02M Potassium Dihydrogen Orthophosphate: water (pH 5.3) in the ratio of 60: 25: 15 respectively. Retention time was found to …
Published in Research and Reviews: A Journal of Toxicology · Vol. 14, Issue 1, 2024 · pp. 17–25 Read article
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Analytical Method Development and Validation of Simultaneous Estimation of Natural Active Constituents Andrographolide and Piperine by UV Method.
Abstract: A simple, accurate, precise, and robust UV-Visible spectrophotometric method was developed and validated for the simultaneous estimation of Andrographolide and Piperine in bulk and combined pharmaceutical dosage forms. Preformulation studies confirmed favorable physicochemical properties for both drugs, including acceptable solubility profiles, melting points, pH values, and partition coefficients. The method development involved determination of λmax values at 224 nm for Andrographolide and 288 nm for Piperine using ethanol as solvent. …
Published in Research & Reviews: A Journal of Pharmacognosy · Vol. 12, Issue 3, 2025 · pp. 33–41 Read article
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Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance
Abstract: The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 54–62 Read article
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A Comprehensive Review of Analytical Method – Development and Method Validation of Digoxin Tablets
Abstract: The main objective of this review is to give an outline of the method development and validation process of digoxin, and this review covers the different types of spectroscopic and chromatographic techniques, such as HPLC, UHPLC-Tandem mass spectroscopy, TLC, and LC-MS. A novel method for the determination of digoxin in biological samples has been developed and validated, focusing on improving sensitivity, specificity, and reproducibility. The method was validated in terms …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 47–58 Read article