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5 articles for “ICH Q2(R1)”
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Stability-Indicating Rp-Hplc Development and Validation for the Estimation of Lercanidipine Hydrochloride Content in Tablet Dosage Form
Abstract: A sensitive, stability-revealing, and easy reverse-phase high-performance liquid chromatographic (RP-HPLC) technique was developed and rationalized to be in a position to determine Lercanidipine hydrochloride in ingested dosing preparations. It was separated by chromatography on a C 18 column using a mobile phase containing 10 mM potassium dihydrogen phosphate buffer and methanol (20:80, v/v; pH 4.0) at a flow rate of 1.0 mL/min and UV detected at 258 nm. The retention …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 1, 2026 · pp. 17–26 Read article
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Analytical Method Development and Validation for Simultaneous Estimation of Paracetamol and Piroxicam by UV Method
Abstract: A new establishment and validation of a simple, precise, accurate and cost effective UV-Visible spectrophotometric method was developed to estimate both Paracetamol and Piroxicam simultaneously in conjoined pharmaceutical dosage forms. This technique was founded on simultaneous equation method of absorbances recorded at 252.0 nm and 282.0 nm of Paracetamol and Piroxicam in methanol respectively and an isosbestic point could be observed at 265.0 nm. It showed very good linearity over …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 14–21 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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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