本文關鍵詞：HPLC法同時測定環(huán)孢素注射液的含量和有關物質(zhì)　出處：《中國藥房》2015年03期 　論文類型：期刊論文

  更多相關文章： 環(huán)孢素 含量測定 有關物質(zhì) 高效液相色譜法

【摘要】：目的:建立同時測定環(huán)孢素注射液含量和有關物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Merck Hibar?C18,流動相為四氫呋喃-0.05 mol/L磷酸溶液(45∶55,V/V),流速為1.0 ml/min,檢測波長為220 nm,柱溫為75℃,進樣量為10μl。結果:環(huán)孢素C、環(huán)孢素B、環(huán)孢素、環(huán)孢素G、環(huán)孢素H、異環(huán)孢素H、異環(huán)孢素A質(zhì)量濃度分別在1.95~195.00、2.03~203.00、0.25~9.90、1.83~182.80、1.26~125.80、1.81~180.80、2.02~202.40μg/ml范圍內(nèi)與各自峰面積積分值呈良好線性關系(r=0.999 9、0.999 9、0.999 9、0.999 9、0.999 9、0.999 8、0.999 9);精密度、穩(wěn)定性、重復性試驗的RSD≤0.3%;環(huán)孢素平均回收率為99.94%,RSD=0.10%(n=3)。結論:本方法準確、可靠、靈敏度高、專屬性強,可用于環(huán)孢素注射液的質(zhì)量控制。
[Abstract]:Objective: to establish a method for simultaneous determination of cyclosporine injection and its related substances. Methods: high performance liquid chromatography (HPLC) was used. The chromatographic column was Merck Hibar? The mobile phase was tetrahydrofuran -0.05 mol/L phosphoric acid solution with a flow rate of 1.0 ml / min and detection wavelength of 220nm. Results: cyclosporine C, cyclosporine B, cyclosporine, cyclosporine G, cyclosporine H and isocyclosporine H. The mass concentration of isocyclosporine A was 1.95 / 195.00 / 2.033.00 / 0.259.90 / 1.83.90 / 1.82.80 / 1.26 / 125.80 respectively. There was a good linear relationship between the integral value of the peak area in the range of 1.81g / ml, 180.80,2.02g / ml, 202.40 渭 g / ml and their respective peak area. 0.999 9, 0.999 9, 0.999 9, 0.999 8, 0.999 9; Precision, stability, repeatability test RSD 鈮，

本文編號：1435777