| 引用本文: | 余永华,马敏康,杨仲杰,石晓宝,张婷.加校正因子的主成分自身对照法测定培哚普利片中有关物质的含量[J].中国现代应用药学,2017,34(10):1427-1431. |
| YU Yonghua,MA Minkang,YANG Zhongjie,SHI Xiaobao,ZHANG Ting.Main Component Self-compare with Calibration Factor Method for Determination of Related Substances in Perindopril Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(10):1427-1431. |
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| 摘要: |
| 目的 采用加校正因子的主成分自身对照法测定培哚普利片中有关物质的含量。方法 采用GL Inertsil C8-3色谱柱（4.0 mm×150 mm，5 μm），以流动相A（用50%高氯酸调节pH至2.5的水溶液）和流动相B（0.03%的高氯酸乙腈溶液）进行梯度洗脱，流速为1.0 mL·min-1，检测波长为215 nm，进样量为20 μL，柱温60℃，测定培哚普利叔丁胺和杂质B、E、F的线性方程，以斜率计算杂质相对于培哚普利叔丁胺的校正因子，用相对保留时间确定各杂质位置。并进行了方法学验证。用相对校正因子计算培哚普利片中杂质B、E和F的含量，并与杂质对照品法测得的结果进行比较。结果 培哚普利杂质B、E和F的相对保留时间分别为0.68，1.14，1.61；校正因子分别为0.77，1.02，1.24；检出限分别为2.24，0.52，1.02 ng；定量限为6.73，1.57，3.06 ng；采用校正因子的主成分自身对照法和外标法测得的结果无显著性差异。结论 该方法简便快速，可准确测定培哚普利片中杂质B、E和F含量。 |
| 关键词: 培哚普利片 有关物质 校正因子 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.10.014 |
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| Main Component Self-compare with Calibration Factor Method for Determination of Related Substances in Perindopril Tablets |
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YU Yonghua1, MA Minkang2, YANG Zhongjie1, SHI Xiaobao1, ZHANG Ting1
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1.Hangzhou SINOVO Pharmaceutical Co., Ltd., Hangzhou 310015, China;2.Zhejiang Center for Drug & Cosmetic Evaluation, Hangzhou 310012, China
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| Abstract: |
| OBJECTIVE To estabilish the main component self-compare with calibration factor method for determination of related substances in perindopril tablets. METHODS The GL Inertsil C8-3 column (4.0 mm×150 mm, 5 μm) was adopted with the mobile phase composed of water (adjusted to pH 2.5 with 50% perchloric acid) and acetonitrile solution(contain with 0.03% perchloric acid), pumped at a flow rate of 1.0 mL·min-1, the detection was carried out at 215 nm and the column temperature was 60℃, the injection volume was 20 μL. The slope of linear equation was used to determine the correction factor between impurity B, E, F and perindopril. The relative retention on time was used to determine the position of impurities. The developed method was validated. The results obtained by the proposed method were compared with those by using the reference standards of impurities to verify the method accuracy. RESULTS The relative retention time of imputiry B, E, F was 0.68, 1.14, 1.61, respectively. The correction factor of imputiry B, E, F was 0.77, 1.02, 1.24, respectively. The limits of detection and quantification of imputiry B, E, F were found to be 2.24, 0.52, 1.02 ng and 6.73, 1.57, 3.06 ng, respectively. There were no significant diferences in the results determined by the external and by the self-compare with calibration factor method. CONCLUSION The method is simple, efficient and accurate for analyzing the related substances B, E and F in perindopril tablets. |
| Key words: perindopril tablets related substances correction factor |
