Application of Stability Indicating HPTLC Method for Quantitative Determination of Escitalopram Oxalate in Pharmaceutical Dosage Form

[摘要] A sensitive, selective, precise and stability indicating high-performance thin-layer chromatographic method of analysis of escitalopram oxalate both as a bulk drug and in formulations 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: acetone: ethanol: ammonia (5:1:1:0.2 v/v/v/v). This system was found to give compact spots for escitalopram oxalate (R_f value of 0.50±0.02). Escitalopram oxalate was subjected to acid and alkali hydrolysis, oxidation, dry heat treatment and photodegradation. Also the peaks of degraded products were well resolved from the pure drug with significantly different R_f values. Densitometric analysis of escitalopram oxalate was carried out in the absorbance mode at 239 nm. The linear regression analysis data for the calibration plots showed good linear relationship with concentration range of 200–1200 ng.spot^-1. The mean value of correlation coefficient, slope and intercept were 0.9987±0.236, 4.186 ±1.53 and 594.8 ±0.856, respectively. The method was validated for precision, robustness and recovery. The limits of detection and quantitation were 20 and 50 ng.spot^-1, respectively. Statistical analysis proves that the method is repeatable and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.

[学科分类] 分析化学

[关键词] Spectrophotometry; Artesunate; Falcigo; Safranin O; Variamine blue