Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TELMISARTAN AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORM BY RP-HPLC

*Pathuri Jnana Nagarjuna, Sree Vidya Parvataneni

ABSTRACT

A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Telmisartan and Amlodipine besylate in combination. The separation was carried out using a mobile phase consisting of acetonitrile: water: triethyelamine (68:31.8:0.2 v/v) with pH 4 adjust by using ortho-phosphoric acid. The column used was C-18 column (Inertsil ODS-3 250*4.6 mm ) with flow rate of 1 ml / min using PDA detection at 240 nm. The described method was linear over a concentration range of 4-60 μg/ml and 10-150 μg/ml for the assay of Amlodipine and Telmisartan respectively. The retention times of Amlodipine and Telmisartan were found to be 2.3 and 2.7 mins respectively. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and the limit of quantification (LOQ) for Amlodipine and Telmisartan were found to be 0.0046 μg/ml and 0.0018 μg/ml, 0.014 and 0.0056 μg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Amlodipine and Telmisartan bulk drug and in its pharmaceutical dosage form.

Keywords: Amlodipine, Telmisartan, RP-HPLC, Pharmaceutical dosage form.