摘要
目的建立RP-HPLC法测定盐酸氟桂利嗪的含量及含量均匀度。方法采用Agela MP C18(4.6mm×250mm,5μm)色谱柱,以甲醇-磷酸盐缓冲液(取磷酸二氢钾1.36g,加水溶解并稀释至1000mL,加三乙胺4mL,用磷酸调节pH至3.5)(75∶25)为流动相,流速0.8mL.min-1,检测波长253nm,柱温30℃,进样量20μL。结果盐酸氟桂利嗪在3.7～24.6μg.mL-1浓度范围内呈良好线性关系(r=0.9999);平均回收率(n=10)为99.9%,RSD为0.9%。结论本法简便、准确,专属性强,重复性好,可用于盐酸氟桂利嗪的含量及含量均匀度测定。
Objective To develop a RP-HPLC method for the determination of content and content uniformity of flunarizine hydrochloride tablets. Methods An Agela MP C18 column （4.6 mm × 250 ram, 5 μm） was used with a mobile phase of methanol-phosphate buffer solution （potassium dihydrogenphosphate 1.36 g, water dissolved and diluted into 1000 mL, plus three ethylamine 4 mL, adjust to pH 3.5 with phosphoric acid） （75 ： 25）. The flow rate was 0. 8 mL · min-1, the detection wavelength was 253 nm, the column temperature was 30 ℃, and the volume of injection was 20 vL. Results A good linear relation of flunarizine hydrochloride was observed within the range of 3.7-24. 6 μg · mL-1 （r = 0. 9999）. The average recovery was 99.90/6 with RSD of 0. 9% （n = 10）. Conelusion The method is simple, accurate, highly selective and repeatable. It can be applied to determine the content and the content uniformity of flunarizine hydrochloride tablets.
出处
《中国药事》
CAS
2013年第4期426-428,共3页
Chinese Pharmaceutical Affairs
