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验证的用于测定原料药和药物制剂中莫西沙星的分光光度法。

Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations.

作者信息

Motwani Sanjay K, Chopra Shruti, Ahmad Farhan J, Khar Roop K

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2007 Oct;68(2):250-6. doi: 10.1016/j.saa.2006.11.023. Epub 2006 Nov 24.

Abstract

New, simple, cost effective, accurate and reproducible UV-spectrophotometric methods were developed and validated for the estimation of moxifloxacin in bulk and pharmaceutical formulations. Moxifloxacin was estimated at 296 nm in 0.1N hydrochloric acid (pH 1.2) and at 289 nm in phosphate buffer (pH 7.4). Beer's law was obeyed in the concentration range of 1-12 microg ml(-1) (r2=0.9999) in hydrochloric acid and 1-14 microg ml(-1) (r2=0.9998) in the phosphate buffer medium. The apparent molar absorptivity and Sandell's sensitivity coefficient were found to be 4.63 x 10(4) l mol(-1) cm(-1) and 9.5 ng cm(-2)/0.001 A in hydrochloric acid; and 4.08 x 10(4) l mol(-1) cm(-1) and 10.8 ng cm(-2)/0.001 A in phosphate buffer media, respectively indicating the high sensitivity of the proposed methods. These methods were tested and validated for various parameters according to ICH guidelines. The detection and quantitation limits were found to be 0.0402, 0.1217 microg ml(-1) in hydrochloric acid and 0.0384, 0.1163 microg ml(-1) in phosphate buffer medium, respectively. The proposed methods were successfully applied for the determination of moxifloxacin in pharmaceutical formulations (tablets, i.v. infusions, eye drops and polymeric nanoparticles). The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming and hence can be suitably applied for the estimation of moxifloxacin in different dosage forms and dissolution studies.

摘要

已开发并验证了新的、简单、经济高效、准确且可重现的紫外分光光度法,用于测定原料药和药物制剂中的莫西沙星。莫西沙星在0.1N盐酸(pH 1.2)中于296nm处测定,在磷酸盐缓冲液(pH 7.4)中于289nm处测定。在盐酸中,1 - 12μg ml(-1)的浓度范围内符合比尔定律(r2 = 0.9999),在磷酸盐缓冲液介质中,1 - 14μg ml(-1)的浓度范围内符合比尔定律(r2 = 0.9998)。在盐酸中,表观摩尔吸光系数和桑德尔灵敏度系数分别为4.63×10(4) l mol(-1) cm(-1)和9.5 ng cm(-2)/0.001 A;在磷酸盐缓冲液介质中分别为4.08×10(4) l mol(-1) cm(-1)和10.8 ng cm(-2)/0.001 A,分别表明所提出方法的高灵敏度。根据ICH指南,对这些方法的各种参数进行了测试和验证。在盐酸中的检测限和定量限分别为0.0402、0.1217μg ml(-1),在磷酸盐缓冲液介质中分别为0.0384、0.1163μg ml(-1)。所提出的方法已成功应用于药物制剂(片剂、静脉输液、眼药水和聚合物纳米颗粒)中莫西沙星的测定。结果表明,该方法准确、精密且可重现(相对标准偏差<2%),同时简单、廉价且耗时较少,因此可适用于不同剂型中莫西沙星的测定和溶出度研究。

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