Development and Validation of a Stability Indicating HPTLC Method for Estimation of Artemether in Bulk and Formulated dosage form

摘要

A simple, sensitive and precise high-performance thin-layer chromatographic (HPTLC) method of analysis for artemether in bulk and prepared parental formulation was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: glacial acetic acid (9:1:0.5, v/v/v) as mobile phase. Densitometric analysis of artemether was carried out in the absorbance mode at 235 nm. The optimised chromatographic conditions gave compact spots for artemether (Rf value of 0.57 ± 0.03). The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9930 in the concentration range 4000-24000 ng per spot. The method was validated for precision, accuracy, recovery and robustness. The limits of detection and quantitation were 2101.5 and 3697.74 ng per spot, respectively. The proposed method was optimized and validated as per the ICH guidelines.