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Abstract

VALIDATED LIQUID CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF ANTIHYPERTENSIVE MIXTURE IN PHARMACEUTICAL DOSAGE FORMS

Napa.Delhiraj *, Sockalingam.Anbazhagan

ABSTRACT

A rapid and precise RP-HPLC method for determination of Hydralazine and Hydrochlorothiazide in bulk and pharmaceutical dosage forms. Hydralazine & Hydrochlorothiazide are found to be degraded together under different set of conditions as followed according to ICH guidelines and the degradants so formed along with Hydralazine & hydrochlorothiazide are separated by using INERTSIL ODS C18 (150 x 4.6, 5μ) using mobile phase 0.01M potassium dihydrogen orthophosphate buffer, pH was adjusted to 4.8 with ortho phosphoric acid and acetonitrile (60:40) with a flow rate of 1ml/min, with a detection wavelength of 217nm for both the compounds with a injection volume of 20μl. The method was validated for selectivity, linearity, accuracy, robustness, precision and specificity. The results were indicating the method was selective in analysis of both Hydralazine and hydrochlorothiazide in the presence of degradation products formed under various stress conditions.

Keywords: Hydralazine, Hydrochlorothiazide, INERTSIL ODS C18, Validation Stability.


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