Determination of the Related Substances in Anastrozole by Improving HPLC
10.6039/j.issn.1001-0408.2017.09.34
- VernacularTitle:改进HPLC法测定阿那曲唑原料药中的有关物质
- Author:
Liyun ZHOU
;
Tingxia HU
;
Hong LI
;
Tongwei YAO
- Keywords:
Anastrozole;
Related substance;
HPLC
- From:
China Pharmacy
2017;28(9):1275-1278
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of related substances in anastrozole. METHODS:HPLC was performed on the column of Welch Materials XB C18 with mobile phase of acetonitrile-water(35:65,V/V)at a flow rate of 1.0 mL/min,detection wavelength was 210 nm,column temperature of 25 ℃,and the injection volume was 20 μL. RESULTS:Only one impurity(impurity A)was detected in anastrozole,the linear range was 0.1-1.6 μg/mL(r=0.9996);limit of quantitation was 0.1 μg/mL,limit of detection was 0.02 μg/mL;RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 98.95%-105.29%(RSD%=1.78%,n=9). CONCLUSIONS:The method is simple,accurate,and can be used for the determination of related substances in anastrozole.
