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QbD‐based development of an extraction procedure for simultaneous quantification of telmisartan, amlodipine besylate and chlorthalidone in combination complex matrix formulation
Author(s) -
Palakurthi Ashok Kumar,
Dongala Thirupathi,
Yalavarthi Ravindra Kumar,
Anireddy Jayashree
Publication year - 2020
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.4755
Subject(s) - chlorthalidone , chemistry , amlodipine , telmisartan , chromatography , matrix (chemical analysis) , extraction (chemistry) , quality by design , pharmacology , diuretic , medicine , particle size , blood pressure
Abstract The main objective of this study was to establish an efficient extraction procedure for the estimation of telmisartan, amlodipine and chlorthalidone from their combination in sample matrix using an analytical quality by design approach. Initial screening studies were performed for optimization of a suitable diluent to extract active components from sample matrix. Further, the same study was extended for the identification of critical method attributes and the factors affecting the analytical target profile. This study also explains the rugged and robust quantitative determination of combinations drugs with a shorter run time. The design of experimental studies confirms that the current center point parameters are well suited to recoveries. The chromatographic separation was achieved with an X‐Terra RP8, 150 × 4.6 mm, 3.5 μm column with an isocratic mobile phase (mixture of 20 m m aqueous ammonium acetate and acetonitrile). To demonstrate the stability‐indicating nature of the optimized method, forced degradation studies were conducted and proved. The optimized method was validated according to International Conference on Harmonization guidelines.