Stability Indicating Rp-Hplc Method Developme...

Stability Indicating Rp-Hplc Method Development and Validation for the Simultaneous Estimation of Telmisartan and Azelnidipine in Tablet Dosage Form

Author Name : Parikh Mansi Brijeshbhai, Dr. Pankti Dalwadi, Ms. Neetu Dharu

ABSTRACT

A reverse phase high performance liquid chromatography method was developed for the simultaneous estimation of Telmisartan and Azelnidipine in Tablet dosage form has been developed. The separation was achieved by Hyperchrom ODS C18 Column (250*4.6mm) column and Buffer 0.05M Potassium dihydrogenortho phosphate Buffer (pH-4.0): Methanol (60:40) as a mobile phase, at a flow rate 1ml/min. Detection was carried out at 215nm. Retention time of Telmisartan and Azelnidipine were found to be 3.440 and 5.693 minutes respectively. The method has been validated for linearity, accuracy, precision and robustness. Linearity observed for Telmisartan and Azelnidipine20-60μg/ml and 40-120 μg/ml respectively. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Telmisartan and Azelnidipinein Tablet dosage form. The drug was subjected to stress condition of acid, base, oxidation, photolysis and thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form.

Keywords: Telmisartan and Azelnidipine, Stability indicating RP-HPLC Method, Validation