HPLC-PDA方法检测柴辛注射液中非法添加的克林霉素
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摘要
建立柴辛注射液中非法添加克林霉素的HPLC-PDA检查方法。采用十八烷基硅烷键合硅胶色谱柱,流动相为磷酸二氢钾溶液(6.8 mg/mL,用25%氢氧化钾调节pH值为7.5)与乙腈的梯度洗脱,采用二极管阵列检测器,采集波长范围为210～400 nm,分辨率为1.2 nm,记录210 nm波长处的色谱图。结果显示,在该色谱条件下,柴辛注射液制剂空白及溶剂空白对克林霉素的测定无干扰,峰纯度检查及光谱相似度检查均符合要求;克林霉素检出限为2 g/L,平均添加回收率为99.1%。该方法准确性高、操作简单,可用于柴辛注射液中非法添加克林霉素的检测。
In order to establish a HPLC-PDA method for the detection of clindamcin illegally added in Chaixin Injection,the C_(18) column was used,the mobile phase was potassium dihydrogen phosphate(6.8 mg/mL,with pH 7.5 adjusted by 25%potassium hydroxide) and acetonitrile with the mode of gradient elution, the PDA detector was used, the acquisition wavelength range was from 210 nm to 400 nm,the resolution was 1.2 nm,the 210 nm chromatogram was recorded. In this condition,the detection of clindamycin was not disturbed by Chaixin Injection or the solvent,the peak purity test and spectral similarity test all met the requirements; the detection limit of clindamycin was 2 g/L,the average recovery rate was 99.1%.This method was simple and accurate,which could be used to detect clindamycin illegally added in Chaixin Injection.
In order to establish a HPLC-PDA method for the detection of clindamcin illegally added in Chaixin Injection,the C_(18) column was used,the mobile phase was potassium dihydrogen phosphate(6.8 mg/mL,with pH 7.5 adjusted by 25%potassium hydroxide) and acetonitrile with the mode of gradient elution, the PDA detector was used, the acquisition wavelength range was from 210 nm to 400 nm,the resolution was 1.2 nm,the 210 nm chromatogram was recorded. In this condition,the detection of clindamycin was not disturbed by Chaixin Injection or the solvent,the peak purity test and spectral similarity test all met the requirements; the detection limit of clindamycin was 2 g/L,the average recovery rate was 99.1%.This method was simple and accurate,which could be used to detect clindamycin illegally added in Chaixin Injection.
引文
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