ABSTRACT

Simple, specific, accurate, precise and reproducible and robust method have been developed and validated for the Simultaneous Estimation of Clonidine HCl and Hydrochlorothiazide in tablet. The Reverse Phase High Performance Liquid Chromatography, the chromatographic system was equipped with Kromasil C18 column and UV detector set at 254 nm, in conjunction with a mobile phase of 0.1M Sodium Dihydrogen Phosphate buffer and Acetonitrile in the ratio of 70:30 % v/v (pH 3.0, adjusted with 1% orthophosphoric acid) at a flow rate of 1.5 mL/min. The described method was linear over a concentration range of 50- 300 ?g/mL for Clonidine HCl and Hydrochlorothiazide. The retention time of Clonidine HCl was 5.230 ± 0.26 min and Hydrochlorothiazide was 2.458 ± 0.006 min. The % recoveries of the both the drugs were found to be 99.32 % - 101.55 % and 99.69 % - 101.00 % for Clonidine HCl and Hydrochlorothiazide respectively. Methods were statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines and can be used for analysis of combined tablet formulation. Clonidine HCL and Hydrochlorothiazide were subjected to stressed conditions of acid degradation, base degradation, oxidative degradation and thermal degradation under same chromatographic condition. The stress samples were assayed on RP-HPLC system. Keywords: Clonidine HCL, Hydrochlorothiazide, RP-HPLC method, Force Degradation Study
Publication date: 01/11/2023

https://ijbpas.com/pdf/2023/November/MS_IJBPAS_2023_7507.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.11.7507