Aziz F, Gupta A, Khan M F
Ranbaxy Research Laboratories, R & D 3, Gurgaon-122 001, India.
Indian J Pharm Sci. 2010 Mar;72(2):252-5. doi: 10.4103/0250-474X.65030.
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of cyclosporine in capsule dosage form. XTerra C18 column was used as stationary phase with mobile phase acetonitrile in combination with 0.1% trifluoro acetic acid buffer and pH is adjusted to 1.4. Method was developed in an isocratic run of 20% trifluoro acetic acid with 80% acetonitrile for 10 min, at flow rate of 1 ml/min. Effluents were monitored at 210 nm. Retention time of cyclosporine was 3.855 min. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness and solution stability. Limit of quantification and limit of detection of cyclosporine was found to be 100 ng/ml and 200 ng/ml. Recovery was found to be in the range of 98.08-101.55%. The proposed method was successfully applied for the quantitative determination of cyclosporine in a capsule dosage form.
建立了一种简单、特异、准确的反相高效液相色谱法，用于测定胶囊剂型中的环孢素。采用XTerra C18柱作为固定相，流动相为乙腈与0.1%三氟乙酸缓冲液混合，pH调至1.4。该方法采用20%三氟乙酸与80%乙腈的等度洗脱，洗脱时间为10分钟，流速为1毫升/分钟。在210纳米处监测流出物。环孢素的保留时间为3.855分钟。该方法在特异性、线性、准确度、精密度、定量限、检测限、稳健性和溶液稳定性方面得到了验证。环孢素的定量限和检测限分别为100纳克/毫升和200纳克/毫升。回收率在98.08%-101.55%之间。所提出的方法成功地应用于胶囊剂型中环孢素的定量测定。
