Development And Validation of HPTLC Method For Simultaneous Estimation of Azelnidipine and Metoprolol in Combined Dosage Form

Azelnidipine, a calcium channel blocker, and Metoprolol, a beta-blocker, are commonly prescribed for managing stage 2 hypertension. This study presents the development and validation of a High-Performance Thin-Layer Chromatography (HPTLC) method for their simultaneous estimation in a combined dosage form. The method was validated following ICH Q2(R1) guidelines, confirming its accuracy, precision, specificity, linearity, and robustness. Chromatographic separation was performed using an isocratic elution with a mobile phase composed of Chloroform, Ethyl acetate, and Methanol (6.5:3.5:0.1 v/v/v). A silica gel 60F-254 aluminum plate was employed as the stationary phase, with detection carried out at 252 nm. This validated method offers a reliable analytical approach for quality control in the pharmaceutical industry.