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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