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Validated HPLC method for quantifying permethrin in pharmaceutical formulations.

机译:经验证的HPLC方法可定量药物制剂中的苄氯菊酯。

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摘要

An isocratic HPLC method for permethrin determination in raw material and pharmaceutical presentations as lotion and shampoo has been developed and validated following ICH recommendations. Cis and trans- isomers, impurities and degradation products are well separated. The chromatographic analysis were performed on a 4 microm particle C-18 Nova-Pak (Waters, Madrid, Spain) column (15 x 0.39 cm) kept in a Biorad column oven at 35 degrees C. Mobile phase consisted of methanol--water (78:22, v/v) at a flow rate of 1 ml/min. UV detection was performed at 272 nm and peaks were identified with retention times as compared with standards and confirmed with characteristic spectra using the photodiode array detector.
机译:按照ICH的建议,已经开发出了一种等度HPLC方法,用于测定原料和药物中的氯菊酯,如乳液和洗发香波。顺式和反式异构体,杂质和降解产物均能很好地分离。色谱分析是在4微米的C-18 Nova-Pak(Waters,Madrid,Spain)色谱柱上进行的(15 x 0.39 cm)色谱柱,该色谱柱保存在35摄氏度的Biorad柱箱中。流动相由甲醇-水( 78:22,v / v)以1ml / min的流速。 UV检测在272 nm处进行,峰的保留时间与标准品相比有所确定,并使用光电二极管阵列检测器通过特征光谱进行了确认。

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