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@article{204692,
author = {V Raja lokesh},
title = {Analytical Method Development and Validation of Combined Anti-Hypertensive Agents in Bulk And Dosage Forms Using RP-HPLC According To ICH Guidelines},
journal = {International Journal of Innovative Research in Technology},
year = {2026},
volume = {13},
number = {1},
pages = {3332-3335},
issn = {2349-6002},
url = {https://ijirt.org/article?manuscript=204692},
abstract = {A simple, accurate, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Deserpidine and Methyclothiazide in bulk drug substances and pharmaceutical dosage forms. Chromatographic separation was achieved using an Agilent C18 column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of phosphate buffer (pH 4.0) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 1.0 mL/min. Detection was performed at 254 nm. The retention times of Methyclothiazide and Deserpidine were found to be 2.577 min and 3.503 min respectively. The developed method was validated according to ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, LOD, and LOQ. The calibration curves showed excellent linearity in the concentration range of 20–100 µg/mL with correlation coefficients of 0.999 for both analytes. The percentage recoveries ranged from 99–102%, indicating excellent accuracy. Precision studies revealed %RSD values below 2%, confirming method reproducibility. The method demonstrated satisfactory robustness under deliberate variations in chromatographic conditions. The developed RP-HPLC method can be successfully employed for routine quality control analysis of Deserpidine and Methyclothiazide in pharmaceutical formulations.},
keywords = {RP-HPLC, Deserpidine, Methyclothiazide, Method Validation, ICH Guidelines, Pharmaceutical Analysis.},
month = {June},
}
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