盐酸替扎尼定口腔崩解片的含量和有关物质测定  

Determination of Contents and Related Substances in Tiazanidine Hydrochloride Orally Disintegrating Tablet by RP-HPLC

作　　者：余莲[1] 

机构地区：[1]重庆市第五人民医院,重庆400062

出　　处：《中国药业》2008年第1期23-24,共2页China Pharmaceuticals

摘　　要：目的建立测定盐酸替扎尼定口腔崩解片中盐酸替扎尼定含量及其有关物质的高效液相色谱(HPLC)法。方法采用反相高效液相色谱(RP-HPLC)法,以Hypersil C18柱(250mm×4.6mm,10μm)为色谱柱,甲醇-30mmol/L NaH2PO4溶液-三乙胺(15∶85∶0.8,磷酸调节pH值至3.0±0.1)为流动相,检测波长320nm,流速1.0mL/min,柱温为30℃;有关物质检查除检测波长为300nm外,其他条件同含量测定。结果盐酸替扎尼定质量浓度在1.0～10.0μg/mL范围内与峰面积的线性关系良好(r=0.9999),平均加样回收率为99.1%～99.3%,RSD为0.12%～0.15%;有关物质检查条件下检测限为0.05ng(S/N=3),有关物质检查的限量为1.0%。结论所建立的方法准确、简便,适用于盐酸替扎尼定口腔崩解片的质量控制。Objective To establish a RP- HPLC for determination of the contents and the related substances in Tiazanidine Hydrochloride Orally Disintegrating Tablet. Methods RP- HPLC method was adopted. For the content determination,Hypersil C18 column （250 mm ×4.6mm,10μm） was adopted with UV detection at 320 nm, and the mobile phase consisted of methanol-30 mmol/L NaH2PO4 solution-triethy- lamine （ 15 ： 85 ： 0. 8, adjusting pH to 3.0 ＋ 0. 1 with phosphoric acid）. The flow rate was 1.0 mL/min, the tempreture of the column were 30℃ ;for the determination of related substances, the method was same to that of the contents except UV detection at 300 nm. Results For the content determination,the calibration curve was linear （r=0. 999 9） within the range of 1.0- 10. 0 μg/mL for tiazanidine hydrochloride, the average recovery rate was from 99. 1% to 99.3% for three different levels of the amount of tiazanidine, RSD was from 0.12% to 0. 15%. For the determination of related substances, the limit of the amount of tiazanidine hydrochloride determined by the equipment was 0.05 ng（S/N = 3）. And the limit of related substances was 1.0%. Conclusion This method is simple,accurate and effective for testing related substances in Tiazanidine Hydrochloride Orally Disintegrating Tablet and for the content determination. It is suitable for the quality control of Tiazanidine Hydrochlor/de Orally Disintegrating Tablet.

关 键 词：盐酸替扎尼定 反相高效液相色谱法 含量测定 有关物质 

分 类 号：R927[医药卫生—药学] R971