论文部分内容阅读
目的建立测定盐酸罗格列酮片含量及有关物质的HPLC方法。方法采用反相高效液相色谱法,色谱柱为Diamonsil C18(4.6 mm×250 mm,5μm)柱,以0.025 mol/L醋酸铵溶液-乙腈(50∶50)为流动相,检测波长245 nm。结果罗格列酮峰与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好,最低检测限为0.29 ng;罗格列酮浓度在19.57～195.70μg/ml范围内与峰面积呈良好的线性关系,回归方程A=68 525 C+31 152,r=1.000 0(n=6);日内精密度(RSD﹤0.5%)与日间精密度(RSD﹤1.0%)良好;平均回收率为99.8%(RSD=0.3%,n=9);供试品溶液在10 h内稳定。结论本方法准确、灵敏、可靠,专属性强,可用于盐酸罗格列酮片的质量控制。
Objective To establish HPLC method for the determination of rosiglitazone hydrochloride tablets and related substances. Methods Reversed-phase high performance liquid chromatography (HPLC) was performed on a Diamonsil C18 column (4.6 mm × 250 mm, 5 μm) with a mobile phase of 0.025 mol / L ammonium acetate in 50:50 with a detection wavelength of 245 nm. Results The peak of rosiglitazone was separated from the impurity peaks of all the major impurities and degradation products by forced destruction. The minimum detection limit was 0.29 ng. The peak area of rosiglitazone in the range of 19.57 ~ 195.70 μg / ml was good (RSD <0.5%) and daytime precision (RSD <1.0%) were good; the average recovery was Was 99.8% (RSD = 0.3%, n = 9); the test solution was stable within 10 h. Conclusion The method is accurate, sensitive, reliable and specific. It can be used for the quality control of rosiglitazone hydrochloride tablets.