气相法测定羟丙甲纤维素空心胶囊的含量
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摘要
基于醚类化合物与氢碘酸反应生成挥发性碘代烷烃的原理,采用气相色谱法测定羟丙甲纤维素空心胶囊中甲氧基、羟丙氧基的含量。采用Agilent DB-624色谱柱,FID检测器以程序升温的方式进行检测。甲氧基在浓度为2.27～21.35 g/L范围内线性关系良好,平均回收率为98.55%(n=9),RSD为4.4%;羟丙氧基在浓度为0.85～7.17 g/L范围内线性关系良好,平均回收率为105.2%(n=9),RSD为1.8%。本方法准确灵敏,适用于羟丙甲纤维素空心胶囊的含量测定。
Based on the principle of reacting ether compounds with hydroiodic acid to produce volatile iodoalkanes,a GC method for the determination of methoxy and hydroxypropoxy groups in hypromellose capsules was established. The separation was performed on Agilent DB-624 column with FID detector. The linear relationship of methoxy group was good in the range of 2. 27 ～ 21. 35 g/L. The average recovery of methoxy group was 98. 55%( n = 9) and RSD was 4. 4%. The linear relationship of hydroxypropoxy group was good in the range of 0. 85 ～ 7. 17 g/L. The average recovery was 105. 2%( n = 9) and RSD was 1. 8%. The method is accurate,sensitive and suitable for the determination of hypromellose capsules.
Based on the principle of reacting ether compounds with hydroiodic acid to produce volatile iodoalkanes,a GC method for the determination of methoxy and hydroxypropoxy groups in hypromellose capsules was established. The separation was performed on Agilent DB-624 column with FID detector. The linear relationship of methoxy group was good in the range of 2. 27 ～ 21. 35 g/L. The average recovery of methoxy group was 98. 55%( n = 9) and RSD was 4. 4%. The linear relationship of hydroxypropoxy group was good in the range of 0. 85 ～ 7. 17 g/L. The average recovery was 105. 2%( n = 9) and RSD was 1. 8%. The method is accurate,sensitive and suitable for the determination of hypromellose capsules.
引文
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[6]郑金琪,郑国钢,李会林,等.毛细管柱气相色谱法测定羟丙甲纤维素中甲氧基和羟丙氧基的含量[J].中国药学杂志,2009,44(20):1585-1588.
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[2]Phaechamud T,Darunkaisorn W. Drug Release Behavior of Polymeric Matrix Filled in Capsule[J]. Saudi Pharmaceutical Journal,2015,43(6):627-634.
[3]孙武千,王丁杨,欧阳伟虹,等.肠溶型羟丙甲纤维素空心胶囊的包衣工艺优化[J].中国医药工业杂志,2018,49(7):975-980.
[4]杨会英,吴朝阳,张庆生,等.羟丙甲纤维素空心胶囊对药物溶出的影响[J].药物分析杂志,2004(6):651-652.
[5]刘利萍,程丹,孙武千,等.羟丙甲基纤维素空心胶囊的研制[J].中国药学杂志,2018,53(1):40-45.
[6]郑金琪,郑国钢,李会林,等.毛细管柱气相色谱法测定羟丙甲纤维素中甲氧基和羟丙氧基的含量[J].中国药学杂志,2009,44(20):1585-1588.
[7]李赐恩,叶芳,张敏怡,等.气相色谱法测定羟丙甲纤维素中甲氧基和羟丙氧基含量[J].中国药业,2010,19(3):27-28.