文章摘要
程岁寒,程岁寒,张双庆,马灿,张彦.HPLC法测定含体外培育牛黄复方制剂中马来酸氯苯那敏的含量[J].中国药品标准,2019,20(1):31-36
HPLC法测定含体外培育牛黄复方制剂中马来酸氯苯那敏的含量
Determination of Chlorphenamine Maleate in Pediatric Paracetamol, Cultured Calculus Bovis and Chlorphenamine Maleate Granules by HPLC
投稿时间:2018-07-28  修订日期:2019-01-15
DOI:
中文关键词: HPLC  马来酸氯苯那敏  小儿氨酚黄那敏颗粒  体外培育牛黄
英文关键词: HPLC  chlorphenamine maleate  pediatric paracetamol, cultured calculus bovis and chlorphenamine maleate granules  cultured calculus bovis
基金项目:湖北省自然科学基金项目(2017CFB572)
作者单位E-mail
程岁寒 安琪酵母股份有限公司 chengsh@angelyeast.com 
程岁寒 安琪酵母股份有限公司 chengsh@angelyeast.com 
张双庆* 安琪酵母股份有限公司 zsq410@163.com 
马灿 安琪酵母股份有限公司 chengsh@angelyeast.com 
张彦 安琪酵母股份有限公司  
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中文摘要:
      目的:现有测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏(CM)含量的HPLC方法均是针对含有人工牛黄的制剂,由于人工牛黄和体外培育牛黄成分差异巨大,体外培育牛黄干扰这些HPLC法测定CM,所以本研究建立了含体外培育牛黄的小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量测定的新HPLC方法,该法同时也适用于含人工牛黄的小儿氨酚黄那敏颗粒中CM含量测定。方法:采用Intersil ODS-3 C18色谱柱,以磷酸盐缓冲液(取磷酸二氢铵5.75 g,磷酸0.5 mL,加水1000 mL)- 乙腈(78 : 22)为流动相,检测波长为262 nm,流速为 1.0 mL? min-1,柱温为30℃,进样量为20 μL。结果:马来酸氯苯那敏在5 μg? mL-1 ~ 30 μg? mL-1范围内峰面积与测定浓度呈良好的线性关系,回归曲线为:y = 14.45349x - 1.7506,r = 0.9995,准确度为100.7 %,精密度RSD为0.7 %。室温下,马来酸氯苯那敏溶液在24 h内稳定。结论:该方法快速简便,专属性强、重现性好,适用于含体外培育牛黄和人工牛黄的小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量测定。
英文摘要:
      Abstract Objective: The published HPLC methods for the determination of chlorphenamine maleate (CM) in pediatric paracetamol, artificial bezoar and CM granules were not suitable for the assay of CM in the presence of cultured calculus bovis, due to the huge different components between artificial bezoar and cultured calculus bovis. Thus, it was essential to establish a novel HPLC for the measurement of CM in the presence of artificial bezoar or cultured calculus bovis. Method: An Intersil ODS-3 C18 column was employed at a column temperature of 30 °C. A mobile phase consisted of phosphate buffer (5.75 g ammonium dihydrogen phosphate and 1 mL phosphoric acid diluted to 1000 mL water) - acetronitrile (78:22) at a flow rate of 1.0 mL?min-1. The detection wavelength of 262 nm was used and injection volume was 20 μL. Result: CM showed a good linear relationship in the range of 5μg? mL-1 - 30μg? mL-1, y = 14.45349x - 1.7506, r = 0.9995. The accuracy was 100.7% with a precision value of 0.7%. CM solution was stable in 24 h at room temperature. Conclusion: The method was simple, specific and accurate, and could be used to determine the assay of CM in pediatric paracetamol, cultured calculus bovis and CM granules.
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