Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND TELMISARTAN IN TABLET DOSAGE FORM UTILISING SIMULTANEOUS EQUATION AND ABSORBANCE RATIO METHOD

Chandappa*, Lalitha N., Mubeen G. and E. Tejaswini

ABSTRACT

Hypertension is recognized as a major risk factor for cardiovascular and renal diseases and represents the leading cause of mortality worldwide. Nearly 75% of hypertensive patients do not achieve adequate control with monotherapy, thus needing combination treatment. Currently, preferred combinations. An angiotensin-receptor blocker and calcium channel blocker. Some patients will also require a triple combination to achieve blood pressure control.[1] Recently available combination product in the market is Azelnidipine and Telmisartan fixed dose tablet formulation (Azelikem T-40, Telmiwal-AP, Telma-AZ, Emdip T-40) which are the tablet used for treat the hypertension. Two validated uv spectrophotometric methods for the simultaneous estimation of Azelnidipine and Telmisartan in pure powder and in two component dosage forms have been developed, utilising simultaneous equation and absorbance ratio method. The method is based on the measurement of absorbance of Azelnidipine and Telmisartan at their respective wavelengths of 258 nm and 297nm and at the iso absorptive wavelength of 274 nm in methanol. Azelnidipine and Telmisartan at their respective λmax 258 nm and 297nm obeyed Beer’s law in the concentration range 4-10μg/ml and 6-18μg/ml respectively with correlation coefficient 0.9993 and 0.9991 for Azelnidipine and 0.9993 and 0.9991 for Telmisartan. The results have been validated statistically as per ICH guidelines.

Keywords: Azelnidipine; Telmisartan; Simultaneous estimation; absorbance ratio, Validation.