Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND TELMISARTAN IN BULK AND PHARMACEUTICAL FORMULATION BY RP-HPLC

Kavitha Vemula*, Nalla Kumar Ponnuswamy and Bhagavan Raju M.

Abstract

Objective: To develop and validate the RP-HPLC method for simultaneous estimation of amlodipine besylate and Telmisartan in bulk and pharmaceutical formulation. Materials and methods: Simultaneous estimation of amlodipine and telmisertan were carried out by RP-HPLC using Acetonitrile: Phosphate buffer (pH 4.0) (58:42) and column Phenomenex Luna C-18 (150×4.6mm, 5μ) as a stationary phase and peak was observed at 235nm which was selected as a wavelength for quantitative estimation. Results: Method was developed and this method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness and ruggedness studies. Conclusion: All the validated parameters were within the limits. The method was found to be suitable for the estimation of amlodipine besylate and Telmisartan in bulk and pharmaceutical formulation.

Keywords: Amlodipine and Telmisartan, Method development and validation, RPHPLC.