Structural Analysis of Impurities in Aciclovir Tablets by HPLC-MS/MS
- VernacularTitle:阿昔洛韦片中杂质的色谱-质谱结构分析
- Author:
Li WANG
1
;
Guoqing CHEN
1
Author Information
- Publication Type:Journal Article
- Keywords: aciclovir; Q-Exactive Orbitrap-MS; impurities; degradation products; structural identification
- From: Chinese Journal of Modern Applied Pharmacy 2024;41(1):62-70
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE To analysis the structures of the impurities in aciclovir tablets and the compulsory degradation samples by high performance liquid chromatography coupled with hybrid quadrupole orbitrap mass spectrometry technology (HPLC-Q-Exactive Orbitrap-MS). METHODS The HPLC separation was carried out on a Waters Xbridge BEH Shield RP18 (4.6 mm×250 mm, 5 μm) by the gradient elution with a mobile phase consisting of 10 mmol·L–1 ammonium formate solution (0.15% formic acid)(A) and 10 mmol·L–1 ammonium formate solution(0.15% formic acid)-acetonitrile(50∶50)(B), and the detection wavelength was 254 nm. The Q-Exactive Orbitrap-MS was used to determine the precise first-order molecular weight and second-order fragment ions of these impurities, and the structures were identified. RESULTS Aciclovir and its impurities were well separated, and 8 major impurities with content>0.1% were detected and identified in aciclovir tablets and the compulsory degradation samples. Among them, 4 were the impurities listed in the European Pharmacopeia 10.0, and the others were unknown impurities identified for the first time. CONCLUSION The LC-MS/MS method can effectively identify the impurities in aciclovir tablets, which is significant for the production process optimization and quality control.
