Tayade Nitin G, Nagarsenker Mangal S
Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai 400098, India.
J Pharm Biomed Anal. 2007 Feb 19;43(3):839-44. doi: 10.1016/j.jpba.2006.08.029. Epub 2006 Oct 12.
A simple, sensitive, precise and rapid high-performance thin-layer chromatographic (HPTLC) method of analysis for artemether both as a bulk drug and in pharmaceutical formulations was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene-ethyl acetate-formic acid (8:2:0.3, v/v/v) as mobile phase. Densitometric analysis of artemether was carried out in the reflectance mode at 565 nm. The system was found to give compact spots for artemether (R(f) value of 0.50+/-0.03). The linear regression analysis data for the calibration plots showed good linear relationship with r(2)=0.9904 in the concentration range 200-1000 ng per spot. The mean value of correlation coefficient, slope and intercept were 0.9904+/-0.011, 7.27+/-0.11 and 166.24+/-56.92, respectively. The method was validated for precision, accuracy, recovery and robustness. The limits of detection and quantitation were 65.91 and 197.74 ng per spot, respectively. The method has been successfully applied in the analysis of lipid based parenteral formulations and marketed oral solid dosage formulation.
建立并验证了一种用于分析原料药及药物制剂中蒿甲醚的简单、灵敏、精确且快速的高效薄层色谱（HPTLC）方法。该方法采用预涂硅胶60F - 254的TLC铝板作为固定相。溶剂系统由甲苯 - 乙酸乙酯 - 甲酸（8:2:0.3，v/v/v）组成作为流动相。在565 nm处采用反射模式对蒿甲醚进行光密度分析。结果发现该系统能给出蒿甲醚的致密斑点（R(f)值为0.50±0.03）。校准曲线的线性回归分析数据显示在每斑点200 - 1000 ng的浓度范围内具有良好的线性关系，r(2)=0.9904。相关系数、斜率和截距的平均值分别为0.9904±0.011、7.27±0.11和166.24±56.92。该方法在精密度、准确度、回收率和稳健性方面得到了验证。检测限和定量限分别为每斑点65.91 ng和197.74 ng。该方法已成功应用于脂质型注射剂和市售口服固体制剂的分析。
