TY  - JOUR
TI  - Development of an HPLC-QAMS method for simultaneous quantification of two morinidazole impurities, three ornidazole impurities and one levornidazole impurity in morinidazole sodium chloride injection
AU  - Lin, Jie
AU  - Xu, Penghe
AU  - Zhang, Huina
AU  - Wang, Menggan
AU  - Liu, Jianjun
AU  - Zhang, Chunrui
AU  - Zhao, Hangyu
AU  - Yu, Yonghua
JO  - Pakistan Journal of Pharmaceutical Sciences
JA  - Pak. J. Pharm. Sci.
VL  - 39
IS  - 5
SP  - 1590
EP  - 1601
PY  - 2026
DA  - 2026/05
KW  - HPLC
KW  - Morinidazole
KW  - Stability-indicating
KW  - Validation
DO  - 10.36721/PJPS.2026.39.5.REG.15048.1
AB  - Background: Morinidazole is a novel nitroimidazole antimicrobial, and quality control is crucial for ensuring clinical safety, particularly monitoring impurities. Objectives: To develop and validate an HPLC-QAMS method for simultaneous quantification of two Morinidazole impurities, three Ornidazole impurities, and one Levornidazole impurity in Morinidazole Sodium Chloride Injection, with evaluation of environmental friendliness. Methods: Separation was performed using a Waters Symmetry C18 column with 0.05 mol/L potassium dihydrogen phosphate buffer (pH 7.0) and acetonitrile in gradient elution. Flow rate was 1.0 mL/min, column temperature 30°C, detection wavelength 319 nm, and injection volume 20 µL. Impurity quantification was performed using QAMS and compared with the external standard method. Method validation followed ICH guidelines. Results: The method showed good specificity. LOQ and LOD were 0.2 µg/mL and 0.06 µg/mL, respectively. Excellent linearity (r ≥ 0.995) was observed from 0.2–4.0 µg/mL. Recoveries ranged 95–105% (RSD < 2%). System suitability and sample solutions were stable for 30 hours. Analytical Greenness (AGREE) and Blue Applicability Grade Index (BAGI) scores were 0.66 and 80.0, respectively. Results from QAMS and external standard methods were comparable. Conclusion: The established HPLC-QAMS method is accurate, sensitive, and environmentally friendly, suitable for quality control of related impurities in Morinidazole Sodium Chloride Injection, supporting clinical safety evaluation.
ER  -