International Conference on Harmonization Recommended Forced Degradation Studies and Development of a New Validated Isocratic Reverse-Phase Ultra High-Performance Liquid Chromatography Method for the Simultaneous Estimation of Telmisartan and Amlodipine I

Abstract

Objective: The objective of this research work is to develop a simple, rapid, cost-effective, accurate, precise, and robust stability-indicating reversephase ultra-high performance liquid chromatography method for the quantitative estimation of telmisartan (TEL) and amlodipine (AMD) in combined tablet dosage form.
 Methods: The method uses Poroshell 120EC-C18 column (4.6 mm × 50 mm, 2.7 μm) with an optimized mobile phase containing acetonitrile:50 mM ammonium acetate buffer in the ratio (45:55 v/v), pH adjusted to 4.5 with acetic acid. The flow rate was 0.5 ml/min, column temperature at 25°C and detection was monitored by a PDA detector at a wavelength of 245 nm. International Conference on Harmonization (ICH) recommended stress degradation studies were performed on TEL, AMD standard drugs, and tablet formulations; further stressed samples were analyzed by the proposed method.
 Results: Major degradation of TEL and AMD was observed under acidic, alkali, hydrolytic and oxidation conditions. The described method was validated as per the ICH guideline and validation parameters such as system suitability, linearity, accuracy, precision, specificity, and robustness results were within acceptable limits.
 Conclusion: The method was found to be suitable and accurate for quantitative estimation and stability study of title drugs in pharmaceutical preparations.

Design of Experimental Approach for Development of Rapid High Performance Liquid Chromatographic Process for Simultaneous Estimation of Metoprolol, Telmisartan, and Amlodipine from Formulation: Greenness and Whiteness Evaluation

“…The literature documented the implementation of the HPLC technique [ 14 ] for the quantification of AML along with its impurities in formulation. RP HPLC [ 15 ], UPLC [ 16 ], LC-MS [ 17 , 18 , 19 ], and capillary electrophoresis [ 20 ] methods are reported for the analysis of AML along with TEL from the formulations. Yenduri et al [ 21 ] compared the greenness of several HPLC methods documented for the concurrent assessment of TEL and AML.…”