摘要
目的建立苯磺贝他斯汀片剂含量测定的方法。方法采用菲罗门Luna C8(250×4.65mm,5μm)为色谱柱,流动相为磷酸盐缓冲液(取磷酸二氢钾6.8g,加水1000m L使溶解,用磷酸调节pH值至3.0)-乙腈(70∶30),每1000m L流动相中含戊烷磺酸钠1.0g。流速为1.0m L·min^(-1),检测波长为260nm。结果苯磺贝他斯汀在48.1056~64.1408μg·m L^(-1)浓度范围内呈良好的线性相关(r=0.9998),平均回收率为99.67%,RSD为0.17%。结论本法准确可靠,可用于苯磺贝他斯汀片剂的质量控制。
OBJECTIVE To establish a method for determination of bepotastine besilate tablets by HPLC. METHODS HPLC was carried out on column of Luna Cs（250 ×4. 65mm,5μm）. The mobile phase was a solution of sodium 1-pentanesulfonate in a mixture of 0. 05tool · L^-1 potassium dihydrogen phosphate TS, pH 3.0 and acetonitrile（7 ： 3） （lg in 1000mL）. The flow rate of 1.0mL · min^-1, and the detecting wavelength was at 260nm. RESULTS The linear range of bepotastine besilate was 48. 1056 - 64. 1408μg · mL^-1 （r = 0. 9998 ） and the average recovery was 99.67% ,RSD was 0. 17%. CONCLUSION This method is reliable and accurate for the quality control of bepotastine besilate tablets.
出处
《海峡药学》
2017年第5期38-40,共3页
Strait Pharmaceutical Journal
基金
福州市科技计划项目(2014-S-129)
福建省化药技术重大研发平台(No.2014Y2001)
福州市生物制药行业技术创新中心(No.2016-PT-36)
关键词
苯磺贝他斯汀片
HPLC
含量测定
Bepotastine besilate tablets
HPLC
Content determination
