NGHIÊN CỨU XÂY DỰNG QUY TRÌNH ĐỊNH LƯỢNG PROPAN-2-OL TRONG VIÊN NÉN BAO PHIM BẰNG PHƯƠNG PHÁP SẮC KÝ KHÍ VỚI KỸ THUẬT TIÊM PHA HƠI TĨNH 

Summary

The gas chromatographic with static head – space injection method for determination propan-2-ol in coated tablets was reported here. A widebore column was used with ZB-624 as the stationary phase (30 m x 0.53 mm), 3.0 μm in film thickness. Carrier gas: Helium for chromatography, with a linear velocity of 22.5 cm/s. The initial temperature of the column was at 40 ^oC for 1.6 min, then raising the temperature at a rate of 3 ^oC per min to 65 ^oC, next to 175^oC at a rate of 20 ^oC per min and maintaining it for 8 min. Maintaining the temperature of the injection port at 200 ^oC and that of the flame – ionisation detector at 200 ^oC, the equilibration temperature was of 85 ^oC with equilibration time for 20 min. The method was validated following the ICH guidelines: The linearity was good at the range of 1.96 – 294 ppm (r > 0.9995); RSD of intra-and inter-day precision variations < 15.0 %; mean recovery was (92.66 % ± 3.93 %) (RSD = 6.67 %).

Keywords: Propan-2-ol, coated tablets, head – space gas chromatography.

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