科研之友
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摘要
Ketoconazole in tablet dosage forms is encoded in pharmacopoeias. It is analyzed by reversed phase high performance liquid chromatography although it has some disadvantages. The proposed method uses economical materials and meets the requirements for performance characteristics. It was developed on octadecylsilane column (4 x 125 mm; 5 mu m), at 40 degrees C, using a mobile phase mixture containing aqueous triethylamine solution pH=3.3 and acetonitrile (65:35). The flow rate was 1.0 mL/min and the eluate was monitored at 244 nm. This method was statistically validated in terms of linearity, precision, accuracy, specificity and robustness. Assay of six drug products of ketoconazole were determined. The obtained results met whit assay specification (90,0-110,0% of the labeled amount). The proposed method is suitable for determination of ketoconazole in tablet dosage forms.
- 出版日期2016
