摘要
目的建立HPLC法测定替米沙坦氨氯地平片的有关物质。方法替米沙坦检测采用capcell Pak C18色谱柱(4.6 mm×150 mm,5μm),流动相采用含0.2%的磷酸二氢钾和0.38%的庚烷磺酸钠水溶液(磷酸调p H至3.0)和乙腈-甲醇(4∶1),梯度洗脱,流速为1.0 mL·min^-1,检测波长为230 nm;苯磺酸氨氯地平检测采用Xtimate C18色谱柱(4.6 mm×250 mm,5μm),流动相采用甲醇-乙腈-0.7%三乙胺(35∶15∶50),流速为1.0 mL·min^-1,检测波长为237 nm。结果主成分与各已知杂质分离度良好。替米沙坦检测限为0.5ng,定量限为1.8 ng,供试品溶液在室温下24 h内稳定;苯磺酸氨氯地平、杂质Ⅰ检测限分别为0.30、0.58ng,定量限分别为0.97、1.96 ng,杂质Ⅰ平均回收率在101.1%~104.1%,RSD<2%(n=3),供试品溶液在室温条件下24 h内稳定。结论本方法可用于检测替米沙坦氨氯地平片产品质量。
Objective To determine the related substances in telmisartan and amlodipine tablets by HPLC.Methods The determination of telmisartan was performed on a capcell Pak C18 column(4.6 mm×150 mm,5μm).The mobile phase consisted of 0.2%potassium dihydrogen phosphate and 0.38%sodium pentanesulfonate monohydrate solution(diluting phosphoric acid to pH 3.0)and acetonitrile-methanol(4∶1),with linear gradient elution and the flow rate of 1.0 mL·min^-1.The detection wavelength was 230 nm.The determination of amlodipine was performed on an Xtimate C18 column,The mobile phase consisted of methanol-acetonitrile-0.7%triethylamine(35∶15∶50),the flow rate was 1.0 mL·min^-1,and the detection wavelength was 237 nm.Results Related substances were completely separated from the main constituents.The limit of detection of telmisartan was 0.5 ng and the limit of quantification was 1.8 ng,and the sample solution was stable at room temperature within 24 h.The limit of detection of amlodipine and impurityⅠwas 0.30 ng and 0.58 ng,while the limit of quantification was 0.97 ng and 1.96 ng.The recovery of impurityⅠwas 101.1%-104.1%with RSD less than 2%(n=3).The sample solution was stable at room temperature within 24 h.Conclusion The method can be used for the quality control of telmisartan and amlodipine tablets.
作者
王媛
黄青玲
张艳侠
邓燕燕
王夕静
WANG Yuan;HANG Qing-ling;ZHANG Yan-xia;DENG Yan-yan;WANG Xi-jing(Xi’an Xintong Pharmaceutical Research Co.,Ltd,Xi’an 710077)
出处
《中南药学》
CAS
2020年第6期1006-1012,共7页
Central South Pharmacy
基金
陕西省重点研发计划(No.2017ZDXM-SF-025)。
