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目的:建立HPLC-RID法测定和比较不同企业生产的克拉霉素缓释片中骨架辅料羟丙甲纤维素(HPMC)的含量,同时评价该辅料与释放度之间可能存在的相关性。方法:采用TSK-Gel 3000色谱柱(300 mm×7.5 mm,10μm),以50 mmol·L~(-1)氯化钠溶液为流动相进行洗脱,流速0.7 m L·min~(-1),柱温30℃,检测温度30℃,进样量5μL。结果:本法可以有效测定HPMC且与其它峰能良好分离,溶液在24 h内稳定;样品中的HPMC含量为标示量的85%~107%。结论:本方法可以有效地测定克拉霉素缓释片中HPMC含量,同时该辅料含量与该药品的体外释放存在一定的相关性。
OBJECTIVE: To establish a HPLC-RID method to determine and compare the content of hypromellose (HPMC) in the clarithromycin sustained-release tablets produced by different enterprises, and to evaluate the possible correlation between the excipients and the release degree. Methods: TSK-Gel 3000 column (300 mm × 7.5 mm, 10 μm) was used to elute 50 mmol·L -1 sodium chloride solution with a flow rate of 0.7 m L · min -1 ), Column temperature 30 ℃, detection temperature 30 ℃, injection volume 5μL. Results: This method can effectively measure HPMC and separate well with other peaks. The solution is stable within 24 h. The content of HPMC in the sample is 85% -107% of the labeled amount. Conclusion: This method can effectively measure the content of HPMC in clarithromycin sustained-release tablets, and the excipient content has some correlation with the drug release in vitro.