论文部分内容阅读
目的:建立卡波姆类口腔黏附片中盐酸利多卡因的HPLC含量测定方法。方法:通过氯化钙沉淀供试品中的卡波姆,采用Welch C18色谱柱(250 mm×4.6 mm,5μm),流动相为醋酸钠溶液(取冰醋酸50 ml,加水930 ml,用1 mol·l-1氢氧化钠调p H至3.40)-乙腈(70∶30);流速1.0 ml·min-1,检测波长254 nm,柱温40℃,进样量20μl。结果:在0.10~2.00 mg·ml-1的范围内,盐酸利多卡因的浓度与峰面积呈良好的线性关系(r=0.999 9),平均回收率为100.2%,RSD为1.4%(n=9)。结论:本方法简单、准确、重复性好,可用于口腔黏附片中盐酸利多卡因的含量测定。
Objective: To establish a HPLC method for the determination of lidocaine hydrochloride in carbomer oral buccal tablets. Methods: The carbomers in the test samples were precipitated by calcium chloride. The samples were separated on a Welch C18 column (250 mm × 4.6 mm, 5 μm) with a sodium acetate solution (50 ml of glacial acetic acid, 930 ml of water and 1 mol·L-1 sodium hydroxide solution p H to 3.40) -acetonitrile (70:30); the flow rate was 1.0 ml · min-1, the detection wavelength was 254 nm, the column temperature was 40 ℃, and the injection volume was 20μl. Results: There was a good linear relationship between the concentration of lidocaine hydrochloride and the peak area in the range of 0.10-2.00 mg · ml-1 (r = 0.999 9), the average recovery was 100.2% and the RSD was 1.4% (n = 9). Conclusion: The method is simple, accurate and reproducible. It can be used for the determination of lidocaine hydrochloride in oral adhesive tablets.