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Determination of Prilocaine HCl in Pharmaceutical Preparations by GC-MS Method

机译:气相色谱-质谱法测定药物制剂中盐酸普罗卡因

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The novel analytical method using gas chromatography with mass spectrometry detection (GC-MS) method for determination of prilocaine HCl in pharmaceutical preparations were developed and validated. The using lidocaine HCl as the internal standard (IS) was carried out on HP-5MS capillary column. The calibration curves were linear (R = 0.999) in concentration range of 40-1000 ng/mL of prilocaine HCl. The LOD and LOQ values were 15 and 31 ng/mL, respectively. The within- and between-day RSD and RE % values of proposed method were found to be < 3.4 and < 3.5 %. respectively. o-Toluidine was formed in stored on auto sampler during 72 h was determined by proposed method. The developed method can be directly and easily applied for determination of prilocaine HCl without derivatized in pharmaceutical preparations using internal standard methodology.
机译:建立并验证了气相色谱-质谱检测(GC-MS)法测定盐酸丙胺卡因的新方法。在HP-5MS毛细管柱上使用盐酸利多卡因作为内标(IS)。在40-1000 ng / mL盐酸丙胺卡因的浓度范围内,校准曲线呈线性(R = 0.999)。 LOD和LOQ值分别为15和31 ng / mL。发现所提出方法的日内和日间RSD和RE%值分别为<3.4和<3.5%。分别。用建议的方法测定72小时内在自动进样器上储存的邻甲苯胺的含量。所开发的方法可以直接,轻松地用于测定丙胺卡因盐酸盐,而无需使用内标方法在药物制剂中进行衍生化。

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