高效液相色谱法测定注射用甲磺酸加替沙星含量

Determination of Gatifloxacin Mesylate for Injection by HPLC

目的建立注射用甲磺酸加替沙星含量测定方法。方法采用反相高效液相色谱法测定甲磺酸加替沙星含量,色谱柱为C18柱(150mm×4.6mm,5μm);流动相:三乙胺磷酸溶液-乙腈(82:18);流速:1.0ml/min;检测波长:325nm;柱温:30℃。结果加替沙星线性范围为78.8～630.4μg/ml(r=0.9999),80%、100%、120%样品溶液平均回收率分别为99.45%,RSD=1.29%(n=3);99.24%,RSD=0.47%(n=3);99.81%,RSD=0.75%(n=3)。结论本方法操作简便,灵敏,准确,重现性好,可用于该产品的含量测定和质量控制。

Objective To establish the method for the determination of gatifloxacin mesylate for injection. Methods The chromato- graphic condition was as follows： Determination was performed with C18 （150mm × 4.6mm,Strm） as the chromatographic column. The mobile phase was consisted of phosphoric acid - acetonitrile（ 82 ： 18） with a flow rate at 1.0 ml/min. The column temperature was 30~C and the detection wavelength was 325nm. Results Good linear relation was achieved when the gatifloxacin concentration was at the range of 78.8 - 630.4trg/ml（ r = 0. 9999）. At the concentration of 80% ,100% ,120% , the mean recovery were 99.45% （ RSD 1.29% , n = 3 ） ,99.24% （ RSD 0.47% ,n =3 ）,99.81% （RSD 0.75% ,n =3 ）. ,respectively. Conclusion The method is accurate with a good reproducibility and can be used as a quantitative analys for preparation.