HPLC法测定复方莫西沙星滴鼻液中2组分的含量

目的:建立以高效液相色谱法同时测定复方莫西沙星滴鼻液中盐酸莫西沙星及盐酸麻黄碱含量的方法。方法:色谱柱为VP-ODS,流动相为磷酸盐缓冲液(含0·02mol·L-1磷酸二氢钠的0·3%三乙胺水溶液,用磷酸调pH至3·0)-甲醇(60∶40),流速为1·0mL·min-1,检测波长为214nm,进样量为20μL,柱温为30℃。结果:盐酸莫西沙星与盐酸麻黄碱的线性范围分别为0·1～0·8(r=0·9997,n=5)、0·125～1·000μg(r=0·9999,n=5);平均回收率分别为98·94%(RSD=0·89%)、99·67%(RSD=1·26%)。结论:本方法简便、快速、准确、重现性好,可用于该制剂的质量控制。

Determination of 2 Kinds of Components in Compound Moxifloxacin Nasal Drops by HPLC

OBJECTIVE:To establish a HPLC method for a simultaneous determination of moxifloxacin hydrochloride and ephedrine hydrochloride in compound moxifloxacin nasal drops.METHODS:The separation was performed on VP-ODS chromatographic column with column temperature at 30℃. The mobile phase consisted of phosphate buffer solution (which contained 0.02mol·L-1 sodium dihydrogen phosphate and 0.3% triethylamine, adjust pH to 3.0 by phosphoric acid) - methanol(60∶40) with flow rate at 1.0mL·min-1, detection wavelength at 214nm and sample size at 20μL. RESULTS: The linear ranges of moxifloxacin hydrochloride and ephedrine hydrochloride were 0.1～0.8(r=0.999 7,n=5) and 0.125～1.000μg (r=0.999 9, n=5), respectively,and their average recoveries were 98.94% (RSD=0.89%) and 99.67%(RSD=1.26%),respectively.CONCLUSION: The technique is simple, rapid, accurate, and reproducible, and it can be used as the quantity control of compound moxifloxacin nasal drops.