采用定量高效薄层色谱法和液相色谱法测定半酒石酸唑吡坦。

Determination of zolpidem hemitartrate by quantitative HPTLC and LC.

作者信息

El Zeany B A, Moustafa A A, Farid N F

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, 23 El-ahrar St, Cairo, Egypt.

出版信息

J Pharm Biomed Anal. 2003 Oct 15;33(3):393-401. doi: 10.1016/s0731-7085(03)00243-7.

DOI:10.1016/s0731-7085(03)00243-7

PMID:14550858

Abstract

Two methods are described for the determination of zolpidem hemitartrate in presence of its degradation product. The first method was a TLC-UV densitometric one in which the mobile phase methanol: water (20:80) was used for developing the TLC plates. The R(f) of zolpidem hemitartrate was found to be 0.29+/-0.01 and that of its degradation product was 0.59+/-0.01. Linearity range was 0.5-4 microg/spot with mean recovery percentage (99.98+/-0.988)%. The second method was an HPLC method. HPLC was performed on a Bondapack C(18) column. The mobile phase was composed of a mixture of acetonitrile-0.01 M KH(2)PO(4) (40:60). The pH was adjusted to 3.5+/-0.1. Flow rate was 1.2 ml/min. Calibration graphs were linear in the range of 0.5-5 microg/ml with UV detection at 245 nm. Both methods have been successfully applied to pharmaceutical formulations. The results obtained were statistically compared with those obtained by applying the reported methods.

摘要

描述了两种在存在唑吡坦半酒石酸盐降解产物的情况下测定唑吡坦半酒石酸盐的方法。第一种方法是薄层色谱 - 紫外光密度法，其中使用甲醇：水（20:80）的流动相展开薄层板。发现唑吡坦半酒石酸盐的比移值（R(f)）为0.29±0.01，其降解产物的比移值为0.59±0.01。线性范围为0.5 - 4微克/斑点，平均回收率为（99.98±0.988）%。第二种方法是高效液相色谱法。高效液相色谱在Bondapack C(18)柱上进行。流动相由乙腈 - 0.01M磷酸二氢钾（40:60）的混合物组成。将pH调节至3.5±0.1。流速为1.2毫升/分钟。在245纳米处进行紫外检测时，校准曲线在0.5 - 5微克/毫升范围内呈线性。两种方法均已成功应用于药物制剂。将所得结果与应用报道方法获得的结果进行统计学比较。