Patel Satish A, Patel Paresh U, Patel Natubhai J, Patel Madhabhai M, Bangoriya Urvisha V
Shree S.K. Patel College of Pharmaceutical Education and Research, Ganpat Vidyanagar, Kherava-382 711, Mehsana, Gujarat, India.
J AOAC Int. 2007 Sep-Oct;90(5):1272-7.
A liquid chromatographic (LC) method and a UV spectrophotometric method were developed and validated for quantitative determination of linezolid in tablets and injection. The isocratic LC analyses were performed on an RP18 column using a mobile phase composed of methanol-water-acetonitrile (40 + 40 + 20, v/v/v) at a flow rate of 1.0 mL/min. The UV spectrophotometric method was performed at 251 nm. The analytical methods were validated according to International Conference on Harmonization guidelines. The calibration graphs were linear (correlation coefficient > 0.999) in the studied concentration ranges of 0.1 to 10 microg/mL for LC and 2 to 16 microg/mL for UV spectrophotometry. The relative standard deviation values for intraday and interday precision studies were <2%, and the accuracy was >98% for both methods. The specificity of the LC method was proved using forced degradation. Statistical analysis showed no significant difference between the results obtained by the 2 methods. The proposed methods are precise and accurate and can be applied directly to the oral and parenteral pharmaceutical preparations of linezolid.
建立并验证了一种液相色谱(LC)法和紫外分光光度法,用于定量测定片剂和注射液中的利奈唑胺。等度液相色谱分析在RP18柱上进行,流动相由甲醇 - 水 - 乙腈(40 + 40 + 20,v/v/v)组成,流速为1.0 mL/min。紫外分光光度法在251 nm波长处进行。根据国际协调会议指南对分析方法进行验证。校准曲线在所研究的浓度范围内呈线性(相关系数>0.999),液相色谱法为0.1至10μg/mL,紫外分光光度法为2至16μg/mL。日内和日间精密度研究的相对标准偏差值<2%,两种方法的准确度均>98%。通过强制降解证明了液相色谱法的专属性。统计分析表明两种方法所得结果之间无显著差异。所提出的方法准确、精密,可直接应用于利奈唑胺的口服和非肠道药物制剂。