RP-HPLC法测定盐酸萘甲唑啉鼻用剂型凝胶中盐酸萘甲唑啉的含量

Determination of naphazoline hydrochloride in naphazoline hydrochloride nasal forming gel by RP-HPLC

目的用可行的方法对盐酸萘甲唑啉鼻用剂型凝胶进行前处理，并建立高效液相色谱法测定样品中盐酸萘甲唑啉的含量。方法本品是凝胶剂，辅料中含有大分子物质，我们选用合理的方法对样品进行前处理，分离出高分子物质，提取主药成分，用高效液相色谱法测定样品中盐酸萘甲唑啉的含量。结果盐酸萘甲唑啉在10—200mg·L^-1范围内进样量与峰面积呈良好线性关系（r=0．9999），回收率为99．97％，RSD为0．61％（n=9）。结论样品的前处理方法合理可行，用HPLC法测定结果准确、灵敏、重现性好。

Aim To choose a reasonable method dealing with the gel and develop a RP-HPLC method for determination of naphazoline hydrochloride in samples, Methods We chose reasonable method dealing with the gel and separated out the macromolecule substance, distilled the dominating substance. The contents of naphazoline hydrochloride were determined by RP-HPLC, Results There was a good linear relationship between the concentration of beclometasone dipropioonate area value in the range of 10 - 200 mg· L^-1 （ r = 0.999 9 ）. The average recovery of naphazoline hydrochloride were 99.67% with RSD being 0.61% （ n = 9）. Conclusion The sample＇ s preliminary treatment was reasonable and feasible. The determination method of HPLC was highly repeatable and accurate.