Determination method of related substances in risedronate sodium tablets
10.3969/j.issn.1006-0111.2015.01.010
- VernacularTitle:利塞膦酸钠片有关物质的方法学研究
- Author:
Xiuli ZHANG
1
;
Yujia ZHANG
;
Lulu WANG
;
Xiaqin FANG
;
Shaohua CHEN
;
Wensheng ZHENG
Author Information
1. 中国医学科学院北京协和医学院药物研究所药物传输技术及新型制剂北京市重点实验室
- Keywords:
risedronate sodium;
related substances;
HPLC
- From:
Journal of Pharmaceutical Practice
2015;(1):40-43
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a HPLC method for determination of related substances of risedronate sodium tab‐lets .Methods The C18 column ,5 μm ,150 mm × 4 .6 mm ,the buffer solution (3 .22 g tetrabutyl ammonium bromide was added to a buffer solution of 1 000 ml 0 .05 mol/L ammonium chloride ,then adjusted pH to 7 .8 ± 0 .05 by ammonia)‐methanol‐aceto‐nitrile =250:50:25 as mobile phase ,column temperature:room temperature ,flow rate:1 .0 ml/min ,detection length:254 nm . Results Determined by HPLC at high temperature ,acid ,alkali degradation ,the main peak and the impurity peaks were separa‐ted well ,and the peaks had a linear relationship ,Y=1 .28 × 107 X-1 .62 × 105 (r=0 .999 9) .Conclusion The method was rap‐id ,simple ,accurate and sensitive ,and suitable for determination of risedronate sodium tablets related substances .
