Development And Validation Of Chromatographic Method Of Selected Drug

A simple, rapid, and cost-effective high-performance thin-layer chromatography (HPTLC) method was developed and validated for the estimation of Aripiprazole (ARP) in bulk drug and pharmaceutical formulations. The chromatographic separation was performed on precoated silica gel 60F254 plates using a mobile phase comprising Methanol: Ethyl Acetate: Toluene (2:4:8 v/v/v). Densitometric detection was carried out at 254 nm. The method exhibited a well-resolved peak for ARP with an Rf value of 0.53 ± 0.07. The calibration curve showed good linearity in the concentration range of 20–100 ng/spot with a correlation coefficient close to 1.0. The method was validated as per ICH Q2(R1) guidelines for parameters such as specificity, linearity, accuracy, precision, robustness, and stability. Recovery studies showed a percentage recovery within acceptable limits, indicating the accuracy of the method. Stability studies confirmed that ARP remained stable under short-term, long-term, and freeze-thaw conditions. The developed HPTLC method demonstrated high sensitivity, reproducibility, and robustness, making it suitable for routine quality control and stability testing of Aripiprazole in pharmaceutical industries.