验证的高效薄层色谱法同时测定药物剂型中左氧氟沙星半水合物和奥硝唑的含量。

Validated HPTLC method for simultaneous estimation of levofloxacin hemihydrate and ornidazole in pharmaceutical dosage form.

作者信息

Chepurwar S B, Shirkhedkar A A, Bari S B, Fursule R A, Surana S J

机构信息

Department of Pharmaceutical Analytical Chemistry, R.C. Patel College of Pharmacy, Shirpur, Dist-Dhule, Maharashtra State, India.

出版信息

J Chromatogr Sci. 2007 Sep;45(8):531-6. doi: 10.1093/chromsci/45.8.531.

DOI:10.1093/chromsci/45.8.531

PMID:18019564

Abstract

A simple, rapid, and accurate high-performance thin-layer chromatography (HPTLC) method is described for the simultaneous determination of levofloxacin hemihydrate and ornidazole in tablet dosage form. The method is based on the HPTLC separation of the two drugs followed by densitometric measurements of their spots at 298 nm. The separation is carried out on Merck TLC aluminium sheets of silica gel 60 F254 using n-butanol-methanol-ammonia (5:1:1.5, v/v/v) as mobile phase. The linearity is found to be in the range of 50-250 and 100-500 ng/spot for levofloxacin hemihydrate and ornidazole, respectively. The method is successively applied to pharmaceutical formulation because no chromatographic interferences from the tablet excipients are found. The suitability of this HPTLC method for the quantitative determination of the compounds is proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines.

摘要

描述了一种简单、快速且准确的高效薄层色谱（HPTLC）方法，用于同时测定片剂剂型中的左氧氟沙星半水合物和奥硝唑。该方法基于两种药物的HPTLC分离，随后在298 nm处对其斑点进行光密度测定。分离在硅胶60 F254的默克TLC铝板上进行，使用正丁醇-甲醇-氨水（5:1:1.5，v/v/v）作为流动相。发现左氧氟沙星半水合物和奥硝唑的线性范围分别为50-250 ng/斑点和100-500 ng/斑点。该方法成功应用于药物制剂，因为未发现来自片剂辅料的色谱干扰。根据国际协调会议（ICH）指南的要求进行验证，证明了该HPTLC方法对化合物定量测定的适用性。