Analytical Method Development, Validation, and Applications of the HPTLC Densitometric Approach for Simultaneous Quantification of Azelnidipine and Chlorthalidone

Abstract

For the simultaneous quantification of Azelnidipine and Chlorthalidone in synthetic combination, a high performance thin layer chromatographic method was devised that is quick, accurate, selective, and exact. The mobile phase used in the chromatographic analysis was in the ratio of 5: 4.7: 0.3: 0.1 v/v/v/v, and the stationary phase utilised was silica gel 60 F254 as the precoated stationary phase on aluminium plates. A 10 x 20 cm TLC chamber with a 15-minute saturation period was utilised. Azelnidipine and chlorthalidone were found to have retardation factors (RF) of 0.43 0.03 and 0.30 0.02, respectively. At 242 nm, densitometric analysis was performed. Following the ICH Q2 (R1) standard, a validation study was conducted. The calibration plots' regression data revealed a strong linear association with R2 = 0.999 for the concentration ranges of azelnidipine and chlorthalidone, 400–1200 ng band-1 and 600–1800 ng band-1, respectively. The method's precision, accuracy, and robustness were all validated. For azelnidipine and chlorthalidone, the minimum detectable levels were determined to be 26.71 ng band-1 and 38.39 ng band-1, respectively, and the limits of quantitation were found to be 80.94 ng band-1 and 116.033 ng band-1. Azelnidipine and chlorthalidone can be estimated simultaneously for routine analysis, in drug formulations, and in biological matrices, in short, using the proven analytical approach.