反相液相色谱法同时测定片剂中硫酸沙丁胺醇和盐酸溴己新的含量
Simultaneous determination of salbutamol sulphate and bromhexine hydrochloride in tablets by reverse phase liquid chromatography.
作者信息
Pai P N S, Rao G K, Murthy M S, Agarwal A, Puranik S
机构信息
Department of Quality Assurance, Al-Ameen College of Pharmacy, Bangalore-560 027, India.
出版信息
Indian J Pharm Sci. 2009 Jan;71(1):53-5. doi: 10.4103/0250-474X.51957.
A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of salbutamol sulphate and bromhexine hydrochloride. The separation was carried out using a mobile phase consisting of acetonitrile, methanol and phosphate buffer, pH 4 in the ratio 60:20:20 v/v. The column used was SS Wakosil-II C-18 with a flow rate of 1 ml/min and UV detection at 224 nm. The described method was linear over a concentration range of 10-110 mug/ml and 20-140 mug/ml for the assay of salbutamol sulphate and bromhexine hydrochloride, respectively. The mean recovery was found to be 95-105% for salbutamol sulphate and 96.2-102.1% for bromhexine hydrochloride when determined at five different levels.
已开发出一种简单的反相液相色谱法，并随后对其进行了验证，用于同时测定硫酸沙丁胺醇和盐酸溴己新。分离采用由乙腈、甲醇和pH值为4的磷酸盐缓冲液按60:20:20 v/v比例组成的流动相进行。使用的色谱柱为SS Wakosil-II C-18，流速为1 ml/min，在224 nm处进行紫外检测。所述方法在硫酸沙丁胺醇浓度范围为10 - 110 μg/ml、盐酸溴己新浓度范围为20 - 140 μg/ml时呈线性。在五个不同水平测定时，硫酸沙丁胺醇的平均回收率为95 - 105%，盐酸溴己新的平均回收率为96.2 - 102.1%。
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