摘要
目的建立高效液相色谱法测定异福胶囊中有关物质的方法。方法色谱柱为Kromasil C18,柱温为40℃,流动相为甲醇-pH 7.0的磷酸盐缓冲液(0.01 mol·L-1磷酸二氢钾溶液,用0.1 mol·L-1氢氧化钠调pH)(60∶40),检测波长为254 nm,流速为1.0 mL·min-1,进样量为20μL。结果有关物质与主药色谱达到有效分离,1009011批样品中杂质I、醌式利福平、各杂质和分别为0、0.68%、3.2%。结论本方法准确、灵敏度更高,可用于该制剂的有关物质检查。
Objective To establish an HPLC method for the determination of the related substances of Rifampicin and Isoniazid Capsules. Methods The determination was performed with a Kromasil C18 column with the column temperature maintained at 40 ℃ ,and the mobile phase was methanol -pH 7.0 buffer solution （0. 01 mol· L-1 Potassium dihydrogen phosphate,adjust pH with 0. 1 mol·L-＇ Sodium hydroxide} （60：40） with flow rate of 1.0 mL ·min-1. The UV detection wavelength was set at 254 nm and the sample size was 20 μL. Results The relevant substances of 1 were well separated from the chief agent,and the related substances in the sample 1009011 were 0,0. 68% ,3.2% , respectively. Conclusion The proposed method was accurate and sensitive. It was applicable for the detemainatinn of the related substances of Rifam- picin and Isoniazid Capsules.
出处
《药学研究》
CAS
2014年第1期14-15,共2页
Journal of Pharmaceutical Research
关键词
高效液相色谱法
异福胶囊
有关物质
HPLC
Rifampicin and Isoniazid Capsules
Related substances
