DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF TELMISARTAN AND AMLODIPINE IN COMBINED DOSAGEFORM

Abstract

 

Objective: To develop a new stability indicating reversed phase high-performance liquid chromatographic method and to validate for the simultaneous determination of two antihypertensive drugs viz. telmisartan and amlodipine. Methods: Chromatography was carried out on a reversed-phase Hypersil BDS C₁₈ (100 x 4.6 mm, 5µ.) with mobile phase mixture of Buffer and Acetonitrile taken in the ratio 60:40 was used as a mobile phase and the pH was adjusted into 3.5, at a flow rate of 1 mL/min. The UV range was detected at 234 nm for telmisartan and amlodipine. The stability-indicating capability of the method was demonstrated through adequate separation of aged and stress degraded telmisartan and amlodipine stability samples. The different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ) and robustness were determined according to International Conference on Harmonization (ICH Q2B) guidelines. Results: The linearity of the calibration curves for each analyte in the desired concentration range is good (r² >0.999). The recovery of the method was between 100.46percent and 99.91 percent for telmisartan and amlodipine respectively. Conclusion: The proposed stability indicating method is rapid, easy, highly sensitive, precise and accurate and it successfully applied to estimate the amount of telmisartan and amlodipine in the formulations by easily available low cost materials.

Key words: RP-HPLC, Telmisartan and Amlodipine, Stability indicating Assay, method development, validation.