Development and validation of a new stability indicating RP-HPLC method for the determination of Eprosartan and Hydrochlorothiazide


Volume :

10

Issue :

2

Abstract :

A new stability indicating liquid chromatographic method has been developed for the determination of Eprosartan and Hydrochlorothiazide in pharmaceutical formulations (gradient mode; UV detection at 235 nm). Linearity was observed over the concentration range 1-300 μg/ml for Hydrochlorothiazide 19.2-750.3 μg/ml for Eprosartan respectively with regression equations y = 5980.5x+535.64 (R2 = 0.9999) and y = 8199.2x + 565.86 (R2 = 0.9998) respectively. The combined tablet formulation of Eprosartan and Hydrochlorothiazide was subjected to acidic, alkaline, oxidation, thermal, photolytic and humidity degradations and the method was validated as per ICH guidelines. The method was reported to be simple, specific, precise, accurate, robust and useful for the routine analysis of Eprosartan and Hydrochlorothiazide in pharmaceutical dosage forms.

Keyword :

Eprosartan, Hydrochlorothiazide, RP-HPLC, stability-indicating and validation