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8 articles for “ICH standards”
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Analytical Technique Optimization and ICH-Directed Verification of a Reverse Phase HPLC Approach for Quantification of Bupropion Hydrochloride
Abstract: This method was developed for retention time, peak resolution and baseline response using Bupropion Hydrochloride under optimized conditions as validation. The method resulted in two well separated, well defined peaks, a minor peak at 7.5 minutes 12 mV and a main peak at 11.52 minutes 150 mV. At the same time, the baseline has remained stable during the chromatographic run and the fluctuations of noise are very small (0.5 ± …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 2, 2025 · pp. 47–54 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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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
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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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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 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