METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION FOR AZELNIPIDINE & TELMISARTAN IN BULK & PHARMACEUTICAL DOSAGE FORM

RP-HPLC method was developed for the estimation of Azelnidipine and Telmisartan in tablet dosage form. The proposed methods were applied for the determination of drug in tablet dosage form. Determination of Azelnidipine and Telmisartan is equation method. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 270 nm and solving the equation. A rapid and reliable RP-HPLC method was developed and validated estimation of Azelnidipine and Telmisartan in tablet dosage form. The RP-HPLC method was performed C18-(100mm x 4.6 mm,)2.5 ?m particle size in gradient mode, and the sample was analyzed using methanol 75 ml and 25 ml (pH 4.3 0.1% OPA with TEA) as a mobile phase at a flow rate of 0.8 ml/min and detection at 249 nm. By the retention time for Azelnidipine and Telmisartan found 3.20 and 6.23 min respectively. The method was applied to marketed tablet formulations. The tablet assay was performed for combination was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 4-20 and 10-50 g/ml for Azelnidipine and Telmisartan respectively, and recoveries from tablet dosage form were between 100.34 and 101.68 %. The method can be used for routine of the quality control in pharmaceuticals. The RP-HPLC method was found to be simple, economical and rapid as compared to MS method was found to be more accurate, precise and robust. Both these methods can be used for routine analysis of Azelnidipine and Telmisartan in tablet dosage form.