DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF TELMISARTAN AND CILNIDIPINE IN COMBINED TABLET DOSAGE FORM

Abstract

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for simultaneous estimation of Telmisartan and Cilnidipine in combined tablet dosage form. The mobile phase selected was Toluene: Methanol: Glacial acetic acid (8: 2: 1, v/v/v) with UV detection at 260 nm. The retention factor for Telmisartan and Cilnidipine were found to be 0.38 ± 0.004 and 0.62 ± 0.007. The method was validated with respect to linearity, accuracy, precision and robustness. The drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 200-1400ng band-1 and 50-600ng band-1 for Telmisartan and Cilnidipine, respectively. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 100.79 ± 1.38 for Telmisartan and 99.55 ± 1.13 for Cilnidipine. The developed and validated stability indicating method can be used for assessing the stability of Telmisartan and Cilnidipine in bulk drug and pharmaceutical dosage form.