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目的:采用HPLC法测定复方吲哚美辛栓中吲哚美辛和硫酸沙丁胺醇栓的含量。方法:Hypersil C_(18)柱(250 mm×4.6 mm,5μm)。流动相为甲醇-0.02 mol·L~(-1)磷酸二氢钾溶液,梯度洗脱。结果:吲哚美辛及硫酸沙丁胺醇的线性范围分别为35.7～142.8μg·ml~(-1)(r=0.999 9)和6.6～26.6μg·ml~(-1)。(r=0.999 9),平均回收率分别为99.2%和101.4%,RSD分别为1.5%和2.0%(n=9)。结论:方法准确可靠,可以有效地控制复方吲哚美辛沙丁胺醇栓的质量。
Objective: To determine the content of indomethacin and salbutamol sulfate suppositories in compound indomethacin suppositories by HPLC. Methods: Hypersil C_ (18) column (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-0.02 mol·L -1 potassium dihydrogen phosphate solution, gradient elution. Results: The linear ranges of indomethacin and salbutamol sulfate were 35.7-142.8 μg · ml -1 (r = 0.999 9) and 6.6-26.6 μg · ml -1, respectively. (r = 0.999 9). The average recoveries were 99.2% and 101.4%, respectively, with RSDs of 1.5% and 2.0%, respectively (n = 9). Conclusion: The method is accurate and reliable and can effectively control the quality of compound indomethacin salbutamol suppository.