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To improve the liquid chromatographic determination method of cefixime granules related substance.
High performance liquid chromatography was used, YMC-Triart C18 column (250 mm×4.6 mm, 5 μm) was selected, 0.05 mol·L-1 ammonium formate solution (pH 4.7)-methanol was used as mobile phase, flow rate was 1 mL·min-1, and gradient washing was carried out.The injection volume was 10 μL. The detection wavelength was 254 nm.
This chromatographic condition was applied to the detection of cefixime granules. The differences between this method, the pharmacopeial method and the method of USP PF 2018 were compared, and the systematic methodological verification of specificity, linearity, accuracy, precision and durability were completed. Using pharmacopeial methods, baseline separation of degradation impurities A1~A4 or impurities B1~B4 cannot be reached, and current methods cannot be used to determine polymer B and polymer D. The method proposed in this article can make the resolution between cefixime and each specific impurities meet the requirements (R ≥1.5), and can detect and quantify polymer B and polymer D at the same time, and the resolution was better than the current method.
This method improves the separation between cefixime and impurities, more impurities is detected and can accurate quantify specific impurities. This method has high sensitivity and good repeatability, and is suitable for the quality control of cefixime.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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