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.

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), 8 th 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.

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