Singh S, Singh U K, Singh R M, Singh G N, Mathur S C, Saini P K, Yadav A, Gupta V, Duggal D
Dr. K. N. Modi Institute of Pharmaceutical Science, Modinagar, Ghaziabad-201 204, India.
Indian J Pharm Sci. 2011 Sep;73(5):577-9. doi: 10.4103/0250-474X.99019.
A simple, precise, rapid, accurate and economic reverse phase high performance liquid chromatographic method has been developed for the estimation of prulifloxacin in tablet dosage form. The separation was achieved by using octadecylsilane column (C(18)) and KH(2)PO(4) buffer: acetonitrile adjusted to pH 7.3 with triethyl amine in proportion of 10:90 v/v as mobile phase, at a flow rate of 1.0 ml/min. The detection was carried out at 278 nm. The retention time of prulifloxacin was found to be 2.4 min. The limit of detection and limit of quantitation were found to be 0.14 μg/ml and 0.42 μg/ml respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of prulifloxacin in tablet dosage form.
已开发出一种简单、精确、快速、准确且经济的反相高效液相色谱法，用于测定片剂剂型中的普卢利沙星。采用十八烷基硅烷柱（C(18)）进行分离，流动相为KH(2)PO(4)缓冲液：乙腈（用三乙胺调节pH值至7.3，比例为10:90 v/v），流速为1.0 ml/min。检测波长为278 nm。发现普卢利沙星的保留时间为2.4分钟。检测限和定量限分别为0.14 μg/ml和0.42 μg/ml。根据ICH指南，通过评估线性、精密度、准确度和特异性等各种验证参数，确定了该方法的准确性和可靠性。该方法为片剂剂型中普卢利沙星的常规分析提供了一种准确且精确的质量控制工具。
