Matmour, D., Hamoum, N., Hassam, K., CHENAFA, A., Yanallah, K., Merad, Y., Ziani, N. (2023). STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT. test, 46(1), 129-140. doi: 10.21608/bfsa.2023.300772
Derouicha Matmour; Nadjib Hamoum; Khalil Fateh Eddine Hassam; Amel CHENAFA; Khadidja Yanallah; Yassine Merad; Nassima Hamdi Ziani. "STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT". test, 46, 1, 2023, 129-140. doi: 10.21608/bfsa.2023.300772
Matmour, D., Hamoum, N., Hassam, K., CHENAFA, A., Yanallah, K., Merad, Y., Ziani, N. (2023). 'STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT', test, 46(1), pp. 129-140. doi: 10.21608/bfsa.2023.300772
Matmour, D., Hamoum, N., Hassam, K., CHENAFA, A., Yanallah, K., Merad, Y., Ziani, N. STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT. test, 2023; 46(1): 129-140. doi: 10.21608/bfsa.2023.300772

STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT

Bulletin of Pharmaceutical Sciences Assiut University
Volume 46, Issue 1, June 2023, Pages 129-140    PDF (1000.55 K)
Document Type: Original Article
DOI: 10.21608/bfsa.2023.300772
Authors
Derouicha Matmour* 1; Nadjib Hamoum2; Khalil Fateh Eddine Hassam2; Amel CHENAFA3; Khadidja Yanallah4; Yassine Merad3; Nassima Hamdi Ziani2
1Therapeutic and Pharmaceutical Chemistry Laboratory, Pharmacy Department, Faculty of Medecine, University of Sidi Bel-Abbes, 22000, Algeria / Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria
2Quality Control Laboratory, WanyLab, 16002 Algiers, Algeria
3Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria
4Galenic Pharmacy laboratory, University of Oran, 31000, Algeria
Abstract
The main objective of this work was to analysis nine drug related impurities (A-I) by High Performance Liquid Chromatography (HPLC) in five samples (F1-F5) of Fluconazole active pharmaceutical ingredient (API), collected from five pharmaceutical industries installed in Algeria. For the organic related-impurities analysis, a liquid chromatography apparatus HPLC-UV device equipped with an automatic injector and UV/Vis detector and a column (C18), deactivated for the bases, post-grafted (5 μm) and dimensions (w: 0.15 m, Ø: 4.6 mm) were used. Each sample of Fluconazole API was processed according to the related substances procedures of the European Pharmacopoeia (EP), 8th edition. The HPLC related-impurities analysis showed that the F1, F3, F4 and F5 samples had an individual content of specified impurities (A, B and C) and unspecified impurities meeting the required standards with a total of all impurities present meeting with the standard. F2 sample had a high content of unspecified impurity 0.126 % compared to the acceptance limit and a total of impurities 0.387 % meeting the standard. This can be explained either by the sample degradation which may be due to poor storage conditions or the batch from which this sample comes wasn’t well purified during the synthesis route
Keywords
drug related impurities; related substances; unspecified impurities; specified impurities HPLC-UV; Fluconazole
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