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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2012  >  30(1): 49-51,63

LI Jue, JIA Fei, WU Yong-jiang. Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(1): 49-51,63. doi: 10.3969/j.issn.1006-0111.2012.01.013
Citation: LI Jue, JIA Fei, WU Yong-jiang. Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(1): 49-51,63. doi: 10.3969/j.issn.1006-0111.2012.01.013
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Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC

doi: 10.3969/j.issn.1006-0111.2012.01.013
  • 1.

    School of Pharmacy, Zhejiang University, Hangzhou 310012, China;Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China

  • 2.

    Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China

  • 3.

    School of Pharmacy, Zhejiang University, Hangzhou 310012, China

  • Received Date: 2011-04-29
  • Rev Recd Date: 2011-10-08
  • 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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    [4] 郑国钢,方滢芝.RP-HPLC法测定盐酸罗格列酮含量及有关物质[J].药物分析杂志,2005,25(1):104.
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Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC

doi: 10.3969/j.issn.1006-0111.2012.01.013
  • 1. School of Pharmacy, Zhejiang University, Hangzhou 310012, China;Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
  • 2. Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
  • 3. School of Pharmacy, Zhejiang University, Hangzhou 310012, China
  • Received Date: 2011-04-29
  • Rev Recd Date: 2011-10-08

Abstract: 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.

LI Jue, JIA Fei, WU Yong-jiang. Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(1): 49-51,63. doi: 10.3969/j.issn.1006-0111.2012.01.013
Citation: LI Jue, JIA Fei, WU Yong-jiang. Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(1): 49-51,63. doi: 10.3969/j.issn.1006-0111.2012.01.013
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