Stability Indicating HPTLC Method for Mietazapine

Abstract

For the estimation, development, and validation of the medication mirtazapine, a densitometric high-performance thin-layer chromatography (HPTLC) method was created. TLC aluminum plates precoated with silica gel 60 F254 were utilized as the stationary phase during development and validation. A different trial was conducted for development by altering the mobile phase. Butanol, ethyl acetate, and tetrahydrofuran make up the solvent system, with 7:2:1 (v/v/v) as the final mobile phase. The quantitative identification of the mirtazapine was made easier by the detection in an absorbance range of 293 nm. 600 ng/spot was the smallest amount of mirtazapine that could be accurately detected and measured. Validation was performed according to ICH guidelines. In the study of validation of mirtazapine accuracy and linearity data for the calibration plots that showed an accurate linear graph with an R2 value of 0.9983 in the concentration range 500-2500 ng/band. Also determine the method development of various parameters (precision, accuracy, linearity, the limit of detection, the limit of quantification, etc.). For the robustness study of the drug performed by factorial design change; analyze the three factors (saturation time, mobile phase ratio, band length) in terms of the order associated with the main factors. The results of the present work showed that scanning densitometric HPTLC detection was simple, selective, accurate, and proved to be a valuable complementary method for the quantitative evaluation of mirtazapine drugs. To distinguish the drug reaction from that of its degradation products, the stability-indicating method or force degradation method of analysis for mirtazapine was created. Also, characterization of mirtazapine degraded API was performed using UV spectroscopy, FT-IR and DSC.