RESIDUAL SOLVENTS ANALYSIS IN METRONIDAZOLE RAW MATERIAL USING HEAD SPACE GAS CHROMATOGRAPHY

Document Type : Original Article

Authors

1 Therapeutic 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

2 Quality control laboratory, WanyLab, 16002 Algiers, Algeria / Hikma Pharmaceuticals, 16002 Algiers, Algeria

3 Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria

Abstract

In pharmaceutical raw material (PRM), the residual solvents (RS) are residual impurities                   which must be controlled due to their toxicity. In this study, we report the quality control results of residual solvents impurties analysis using head space gas chromatography with flame ionization detector (HS-GC-FID) of six raw materials samples of Metronidazole marketed in Algeria. The GC is equipped with a flame-ionization detector and silica column coated with 1.8 µm layer of phase G43. The carrier gas is nitrogen with a linear velocity of 35 cm/s and a split ratio of 1:5. The column temperature is 40 °C then it rise to 240 °C. The injection temperature is 140 °C and that of detector is 250 °C. 29 organic solvents belongs to classes 1 and 2 were researched whose control is mandatory because of their carcinogenic and intrinsic toxicity, only five solvents were identified in the different samples and the methanol was quantified in M2 sample. All samples collected satisfy the test except M2 sample which contains a slight excess of methanol estimated of 14 ppm. This slight excess show that M2 sample wasn’t well purified and this may be due to the difficulty of solvents complete removal

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