Separation and quantification of azelnidipine and chlorthalidone in a synthetic mixture using optimized HPTLC method

Objectives. - A simple, accurate, and reliable high-performance thin -layer chromatographic technique has been developed and validated for the simultaneous quantitation of azelnidipine and chlorthalidone in bulk and synthetic mixtures. Material and methods. - The procedure was carried out using a precoated silica gel 60 F254 TLC plate with a mobile phase of chloroform, ethyl acetate, and methanol in the ratio of 6.5:3.5:0.6 (by volume). Thin -layer chromatographic densitometry at 240 nm was used to quantify medicines chromatographically. Results. - Over concentration ranges of 250.0 to 1000.0 ng/band for chlorthalidone and 160.0 to 640.0 ng/band for azelnidipine, the high-performance thin -layer chromatography technique was quantitated. This technique produced a tight and well -resolved band at retention factors of 0.67 +/- 0.02 and 0.24 +/- 0.02 for azelnidipine and chlorthalidone, respectively. Data from a linear regression study calibrating this method revealed a strong linear correlation between the two approaches, with regression coefficients of r(2) > 0.99 for both. According to The International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use requirements, the procedures were validated for precision, robustness, accuracy, and specificity. Conclusion. - The developed method was also used to simultaneously estimate azelnidipine and chlorthalidone in a synthetic mixture. The results were found to be in exemplary % assay with label claims. (c) 2023 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.