Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN SULPHATE AND TELMISARTAN USING RP-HPLC METHOD

Dr. S.H. Rizwan, Mohammed Arbaz Sabri*, Samreen Begum, Mehwish Arif and Sabahat Urooj

ABSTRACT

A simple, specific, accurate and precise RP-HPLC method has been developed for the simultaneous estimation of Atorvastatin and Telmisartan in tablet dosage form. Calibration curve was linear with correlation coefficient of 0.999 and 0.999 for Atorvastatin and Telmisartan respectively. The percentage recovery of the drug was found to be in the range of 99.91-100.40 % and 100.12-100.31 % respectively for Atorvastatin and Telmisartan indicating accuracy and reliability of method. The method was found to be precise as indicated by the repeatability of the analytical procedure, showing % RSD < 2%, 0.12 and 1.39 in AUC, respectively for Atorvastatin and Telmisartan. RP-HPLC method was developed using Nucleodur C-18 (150 x4.6mm) 5μm. The samples were analyzed using Acetonitrile: Methanol: phosphate buffer PH 3 (44:11:45) as the mobile phase at the flow rate of 1.5 ml/min in gradient mode and detection wavelength is 210 nm. Both the drugs were eluted within 8 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Atorvastatin and Telmisartanbwas found to be 6.140 and 3.113 minutes respectively. The proposed method was validated as per ICH guidelines. Hence, the developed analytical method can be utilized for the routine simultaneous analysis of Atorvastatin and Telmisartan in tablet dosage form.

Keywords: Atorvastatin and Telmisartan, UV spectrophotometric detector, by RP-HPLC method.