Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC
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摘要: 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, 5 μm)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19.57~195.70 μg/ml范围内与峰面积呈良好的线性关系,回归方程A=68 525Abstract: Objective To establish a HPLC method to determine the content and related substance of rosiglitazone hydrochloride tablets. Methods The analysis was achieved on a Diamonsil C18 column(250 mm×4.6 mm, 5 μm) using a mobile phase of 0.025 mol/L ammonium acetate-acetonitrile (50∶50). The detection wavelength was at 245 nm. Results There was good resolution among the peak of rosiglitazone, the main related substances and the degradable impurities after being destroyed. There was a good linear relationship between the peak area and the concentration of rosiglitazone in the range of 19.57~195.70 μg/ml (r=1.000 0, n=6). Regression equation could be expressed by A=68 525C+31 152, r=1.000 0 (n=6). The precision in a day (RSD﹤0.5%) and during the days (RSD﹤1.0%) were good. The average recovery was 99.8% (RSD=0.3%,n=9) and the limit of detection was 0.29 ng. The solution was stable for 10 hours. Conclusion The method was specific, accurate, sensitive and could be used to determine rosiglitazone.
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Key words:
- rosiglitazone hydrochloride tablets /
- assay /
- related substance /
- HPLC
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