Abstract

REVERSE PHASE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TRITYL CANDESARTAN IN BULK DRUG AND DOSAGE FORMS.

*Dr. Anita Shinde, Dr. Suman Malik, Dr. K. C. Asati, Dr. Amit Asati

Abstract

Trityl Candesartan is an angiotensin II receptor antagonist (more commonly called an "ARB", or angiotensin receptor blocker), Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. It blocks the action of angiotensin-II and therefore relaxes blood vessels. This helps lower blood pressure. A simple, precise and reversed phase liquid chromatographic (RP-LC) method was developed and validated for estimation of Trityl Candesartan. The separation was achieved on C-18 1.7μ, (2.1 X 100) mm, Make: Waters, analytical column with mobile phase consisted of buffer TFA in water: Acetonitrile with UV detection wavelength was at 255 nm and 5μl of sample volume was injected. The retention time of Trityl Candesartan was found 1.4 minute. The method was successfully validated in accordance to ICH guidelines and usp pharmacopeia for accuracy, precision, specificity, linearity. The linear regression analysis data for calibration plots showed good linear relationship correlation factor 0.999 in the concentration range 50-150μg/mL for Trityl Candesartan. The % Recovery/Accuracy was within the range. The percentage RSD for precision method was found less than 2%. Therefore, the proposed method is simple, precise, and fast, so method should be successfully applied for routine analysis of Trityl Candesartan in bulk drug.

Keywords: Accuracy, ICH, Isocratic, Linearity, Precision, RP-LC, validation, USP pharmacopeia.