Patole Sm, Khodke As, Potale Lv, Damle Mc
Department of Quality Assurance, A.I.S.S.M.S. College of Pharmacy, Kennedy Road, Near R.T.O., Pune - 411 001.
J Young Pharm. 2011 Jan;3(1):55-9. doi: 10.4103/0975-1483.76420.
A simple, accurate and precise high-performance thin-layer chromatographic method has been developed for the estimation of Atorvastatin Calcium and Metoprolol Tartarate simultaneously from a capsule dosage form. The method employed Silica gel 60F (254s)precoated plates as stationary phase and a mixture of Chloroform: Methanol: Glacial acetic acid (dil.) :: (9:1.5:0.2 ml %v/v) as mobile phase. Densitometric scanning was performed at 220 nm using Camag TLC scanner 3. The method was linear in the drug concentrations' range of 500 to 2500 ng/spot for Atorvastatin Calcium, also for Metoprolol Tartarate with correlation coefficient of 0.984 for Atorvastatin Calcium and 0.995 for Metoprolol Tartarate respectively. The retention factor for Atorvastatin Calcium was 0.45 ± 0.04 and for Metoprolol Tartarate was 0.25 ± 0.02. The method was validated as per ICH (International Conference on Harmonisation) Guidelines, proving its utility in estimation of Atorvastatin Calcium and Metoprolol Tartarate in combined dosage form.
已开发出一种简单、准确且精密的高效薄层色谱法，用于同时测定胶囊剂型中阿托伐他汀钙和酒石酸美托洛尔的含量。该方法采用硅胶60F(254s)预涂板作为固定相，以氯仿：甲醇：冰醋酸（稀释）::(9:1.5:0.2 ml %v/v)的混合物作为流动相。使用Camag TLC扫描仪3在220nm处进行光密度扫描。该方法在阿托伐他汀钙药物浓度范围为500至2500 ng/斑点时呈线性，酒石酸美托洛尔也是如此，阿托伐他汀钙的相关系数为0.984，酒石酸美托洛尔的相关系数为0.995。阿托伐他汀钙的保留因子为0.45±0.04，酒石酸美托洛尔的保留因子为0.25±0.02。该方法已按照ICH（国际协调会议）指南进行验证，证明其在测定复方剂型中阿托伐他汀钙和酒石酸美托洛尔方面的实用性。
