| 孙爱华,胡文辉.HPLC法测定劳拉西泮片有关物质的含量[J].安徽医药,2016,20(5):866-869. |
| HPLC法测定劳拉西泮片有关物质的含量 |
| HPLC determination of the related substances in iorazepam tablets |
| 投稿时间：2015-10-15 |
| DOI： |
| 中文关键词: 劳拉西泮 色谱法,高压液相 |
| 英文关键词: iorazepam Chromatography,High Pressure Liquid |
| 基金项目: |
|
| 摘要点击次数: 3661 |
| 全文下载次数: 109 |
| 中文摘要: |
| 目的 建立劳拉西泮片的含量及有关物质的HPLC方法。方法 以十八烷基硅烷键合硅胶作为填充剂的ZORBAX SB-C18柱(250 mm×4.6 mm,5 μm)为色谱柱,流动相:0.05 mol·L-1的磷酸二氢铵(含0.5%的三乙胺,用磷酸调pH至2.5)∶甲醇∶乙腈=35∶35∶30；流速:1.0 mL·min-1；检测波长:235 nm；进样量:10 μL；柱温:30℃。结果 劳拉西泮峰及各杂质峰均能良好分离。杂质A浓度与峰面积在1.5 μg·L-1 ～8.048 mg·L-1内线性关系良好。杂质B浓度与峰面积在15.0 μg·L-1～8.224 mg·L-1内线性关系良好。杂质C浓度与峰面积在1.7 μg·L-1～8.144 mg·L-1内线性关系良好;杂质D浓度与峰面积在2.5 μg·L-1～8.032 mg·L-1内线性关系良好；杂质E浓度与峰面积在3.0 μg·L-1～8.032 mg·L-1内线性关系良好。测定样品含量平均值为97.9%,有关物质均符合要求。结论 该方法快速、简单,稳定,重现性好,可作为劳拉西泮片的含量及有关物质的检测方法。 |
| 英文摘要: |
| Objective To determine the related substances and content in iorazepam tablets by HPLC.Methods The chromatographic separation was performed on ZORBAX SB-C18 column(4.6 mm×250 mm,5 μm)that was made by alkyl-bonded silica gels.The mobile phase was 0.05 mol·L-1 ammonium dihydrogen orthophosphate (including 0.5% trimethylamine and pH adjusted to 2.5 with phosphoric acid)∶methanol∶acetonitrile=35∶35∶30.The flow rate was 1.0 mL·min-1,the detection wavelength was 235 nm,the sample size was 10 μL,and the column temperature was set at 30℃.Results The resolution between iorazepam and the other peaks met the requirements.The linearity of related substance Aconcentration and peak area was 1.5 μg·L-1～8.048 mg·L-1.The linearity of related substance Bconcentration and peak area was 15.0 μg·L-1～8.224 mg·L-1.The linearity of related substance Cconcentration and peak area was 1.7 μg·L-1～8.144 mg·L-1.The linearity of related substance Dconcentration and peak area was 2.5 μg·L-1～7.952 mg·L-1.The linearity of related substance Econcentration and peak area was 3.0 μg·L-1～8.032 mg·L-1.Determination of the sample average content was 97.9%,and the related substance met the requirements.Conclusions The method was quick,simple,stable,and well repeatable,which could be used to determine the content of iorazepam tablets and its related substances. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|
