摘要
目的:建立盐酸氨基葡萄糖及其制剂的HPLC含量测定方法。方法:采用Phenomenex Luna NH_2柱(150 mm×4.6 mm,5’m);流动相:磷酸盐缓冲液(取磷酸氢二钾3.5 g,加水1 000 ml使溶解,加入0.25 ml氨水,用磷酸调节p H至7.5)-乙腈(25∶75);流速:1.5 ml·min^(-1);检测波长:195 nm;柱温:35℃;进样量20μl。结果:盐酸氨基葡萄糖在1.6~16.0 mg·ml^(-1)浓度范围线性关系良好(r=0.999 9),片剂及胶囊的平均回收率分别为99.3%和99.5%,RSD均为0.3%(n=9)。结论:该方法简便、准确,专属性强,适合于盐酸氨基葡萄糖及其制剂的质量控制。
Objective： To establish an HPLC method for determining the content of glucosamine hydrochloride and its preparations. Methods： A Phenomenex Luna NH2 column was used, and the mobile phase was ammonium phosphate buffer （ dissolving 3.5 g dipotassium phosphate and 0.25 ml ammonium hydroxide into 1 000 ml water, adjusting pH to 7.5 with phosphoric acid） - acetoni- trile （25：75）. The flow rate was 1.5 ml · min-1 and detection wavelength was 195 nm. The column temperature was 35℃ and the injection volume was 20 μl. Results： The linear range of glucosamine hydrochloride was 1.6-16.0 mg · ml -1 （r =0. 999 9）. The average recovery of glucosamine hydrochloride tablets and capsules was 99.3% and 99.5%, respectively, and RSDs were 0.3% （ n = 9）. Conclusion： The method is simple, accurate and reliable, and suitable for the quality control of glucosamine hydrochloride and its preparations.
出处
《中国药师》
CAS
2016年第2期387-389,共3页
China Pharmacist
