Determination of related impurities in trazodone hydrochloride API by HPLC-MS/MS
10.19778/j.chp.2024.04.008
- VernacularTitle:HPLC-MS/MS法测定盐酸曲唑酮原料药中相关杂质的研究
- Author:
Yanhua FENG
1
;
Ming DENG
Author Information
1. 广西壮族自治区药品检验研究院,南宁 530021
- Keywords:
HPLC-MS/MS;
trazodone hydrochloride;
related impurities;
content determination
- From:
Drug Standards of China
2024;25(4):372-375
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC-MS/MS method for the determination of related impurities in traz-odone hydrochloride API.Methods:The impurities were separated on an Agilent ZORBAX Eclipse Plus C18column(2.1 mm x 100 mm,1.8 μm)using a gradient elution of 0.1％formic acid solution and acetonitrile at a flow rate of 0.2 mL·min-1 at column temperature of 30 ℃,and determined by electrospray ionization source(ESI)com-bined with multiple reaction detection(MRM)in the positive ion mode.Results:The related impurities(triazol-opyridone,trazodone N-oxide,dechlorinated trazodone,4-ethyltrazodone,and trazodone isobutyl ether analogue)in trazodone hydrochloride API were determined.The linear relationship of five impurities was good in correspond-ing concentration ranges with correlation coefficients(r)of more than 0.999 5.The average recoveries varied be-tween 91.9％and 99.4％with RSD ≤3.9％.Trazodone N-oxide and dechlorinated trazodone were detected in all three batches,and extremely trace amounts of 4-ethyltrazodone were detected in two batches.Conclusion:The es-tablished method can determine the content of five related impurities in trazodone hydrochloride API,and can more effectively evaluate and control the quality of trazodone hydrochloride API.
