高效液相色谱法测定复方对乙酰氨基酚片的含量和溶出度

目的: 建立测定复方对乙酰氨基酚片含量和溶出度的方法。方法: 采用高效液相色谱法。色谱条件:采用SHIMADZU Shim-pack C₁₈色谱柱,流动相为甲醇-0.1%醋酸钠溶液(冰醋酸调节pH 3.5)(30∶70),流速1.0 mL·min^-1,检测波长272 nm。按中国药典桨法,采用ZRS-8G智能溶出仪,以0.1 mol·L^-1盐酸溶液为溶出介质测定溶出度。结果: 对乙酰氨基酚、咖啡因、阿司匹林线性范围分别为6.462~161.55 μg·mL^-1(r=0.9999),1.577~39.42 μg·mL^-1(r=0.9999),11.04~276.1 μg·mL^-1(r=0.9999);回收率(n=5)分别为100.1%,100.4%,99.8%,RSD分别为0.53%,0.70%,0.55%。样品溶出度均一性好,在30 min时3个组分溶出度均达到80%。结论: 本方法准确、方便,结果满意,适用于复方对乙酰氨基酚片的含量和溶出度测定。

Objective: To establish an RP-HPLC method for the determination content and dissolution of compound paracetamol tablets. Methods: HPLC analysis was carried out by using SHIMADZU Shim-pack C₁₈ column and a mixture of methanol and 0.1% sodium acetate adjusted to pH 3.5 with acetic acid glacial(30∶70,) as mobile phase.The flow rate was 1.0 mL·min^-1,and the detection wavelength was 272 nm. Results: The calibration curves for paracetamol,caffeine and aspirin were linear over the ranges of 6.462-161.55 μg·mL^-1(r=0.9999),1.577-39.42 μg·mL^-1(r=0.9999),11.04-276.1 μg·mL^-1(r=0.9999),respectively; The average recoveries(n=5) were 100.1%,100.4%, 99.8%, and RSD were 0.53%, 0.70%, 0.55%. The dissolution of different batches of compound paracetamol tablets fulfilled the requirements and had the similar nature. Conclusion: This method is accurate, convenient and suitable for determination content and dissolution of compound paracetamol tablets.

1 Drug Specifications Promulgated by the Ministry of Public Health,P R China(Volume 1,Chemical Medicines and Preparations)[卫生部药品标准(化学药品及制剂第一册)].1996.84
2 ChP(中国药典).2010.Vol Ⅱ(二部):384
3 ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录)ⅩC,method Ⅱ(第二法)
4 LI Xiao-yan(李晓燕),RAN Xiao-jing(冉晓静).HPLC determination of paracetamol,acetylsalicylic acid and caffeine in compound paracetamol tablets(HPLC法测定复方对乙酰氨基酚片中对乙酰氨基酚、乙酰水杨酸及咖啡因的含量).Chin J Pharm Anal(药物分析杂志),2008,28(5):801
5 ZENG Jie(曾洁),LOU Yong-ming(楼永明),LV Rong-jian(吕榕健).HPLC determination of paracetamol caffeine and aspirin in compound paracetamol tablets(HPLC法测定复方对乙酰氨基酚片中对乙酰氨基酚、咖啡因、乙酰水杨酸的含量).Strait Pharm J(海峡药学),2005,17(5):37
6 YAN Dong-mei(颜冬梅),TU Ling-lan(屠凌岚),SONG Zhong-ying(宋忠英),et al.HPLC determination of the content and dissolution of epristeride tablets(高效液相色谱法测定爱普列特片的含量和溶出度).Chin J Pharm Anal(药物分析杂志),2007,27(8):1264
7 YAO Jing(姚静),AN Ning(安宁),WU Jian-min(吴建敏),et al.Study on dissolution test of valsartan capsules(缬沙坦胶囊溶出度方法的考察).Drug Stand China(中国药品标准),2010,11(2):138