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QbD based development of Extraction Procedure for simultaneous Quantification of Telmisartan, Amlodipine Besylate and Chlorthalidone in combination complex matrix formulation.

The main objective of this study is to establish an efficient extraction procedure for the estimation of Telmisartan, Amlodipine and Chlorthalidone from their combination of sample matrix by using Analytical Quality by Design (AQbD) approach. Initial screening studies were performed for optimization of suitable diluent to extract active components from sample matrix. Further, the same study has been extended for the identification of critical method attributes (CMAs) and the factors affecting the analytical target profile (ATP). This study also explains the rugged and robust quantitative determination of combinations drugs with a less run time. Design of experimental studies confirms that, the current center point parameters are well suited for recoveries. The chromatographic separation was achieved with X-Terra RP8, 150 x 4.6 mm, 3.5μm column with an isocratic mobile phase (mixture of 20 mM aqueous ammonium acetate and acetonitrile). To demonstrate the stability indicating nature of optimized method, forced degradation studies were conducted and proved. The optimized method was validated according ICH guidelines.