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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2017  >  35(1): 60-63,69

WU Heqin, CHEN Zhaoxia. Assay of cyproheptadine hydrochloride and the related substances with HPLC[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 60-63,69. doi: 10.3969/j.issn.1006-0111.2017.01.014
Citation: WU Heqin, CHEN Zhaoxia. Assay of cyproheptadine hydrochloride and the related substances with HPLC[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 60-63,69. doi: 10.3969/j.issn.1006-0111.2017.01.014
shu

Assay of cyproheptadine hydrochloride and the related substances with HPLC

doi: 10.3969/j.issn.1006-0111.2017.01.014

  • Changzhou Siyao Pharm, Changzhou City, Changzhou 213004, China

  • Received Date: 2016-09-03
  • Rev Recd Date: 2016-10-14
  • Objective To establish a HPLC method for the assay of cyproheptadine hydrochloride and the related substances. Methods The HPLC was performed on an Agilent Eclipse XDB-C18 column (4.6 mm×250 mm, 5 μm) at the temperature of 25℃ with the mobile phase of acetonitrile-buffer Solution (Dissolve 2.16 g of sodium octane-1-sulfonate with about 500 ml of water and mix well. Add 10.0 ml of glacial acetic acid and 5.0 ml of triethylamine, and dilute with water to 1 000 ml, mix well and adjust to pH 7.0 with triethylamine) (85:15,V/V). The flow rate was 1.0 ml/min and detection wavelength was 286 nm. The injection volume was 10 μl. Results The calibration curves of cyproheptadine hydrochloride, impurity A, B and C showed good linear response in the range from 0.056 2 to 5.620 μg/ml (r=0.999 8), 0.052 4 to 5.240 μg/ml(r=1.000 0),0.050 3 to 5.032 μg/ml (r=0.999 9) and 0.053 2 to 5.316 μg/ml(r=0.999 8) respectively. The LOQs for cyproheptadine hydrochloride, impurity A, B and C were within 0.049-0.054 μg/ml, LODs were within 0.019-0.022 μg/ml with recovery between 98%-100%. RSD of repeatability was 5.5% (n=6). Conclusion This method gave an accurate and reliable results. It can be used for quality control of cyproheptadine hydrochloride.
  • [1] 张式凡. 盐酸赛庚啶[J].江苏医药,1980,8(3):30.
    [2] 吕竹芬,谢清春,申楼. 高效液相色谱法测定盐酸赛庚啶片中盐酸赛庚啶的含量[J].海峡药学,2011,23(10):52-54.
    [3] 陈繁华曾玉梅庄晓娜. HPLC法测定盐酸赛庚啶片的含量及其有关物质[J].中国药师,2015,18(10):1827-1829.
    [4] 国家药典委员会.中华人民共和国药典2015年版二部[S].北京:中国医药科技出版社,2015:1111-1112.
    [5] The European Pharmacopeial Convention. European Pharmacopeia[S]. 8th ed,2014:1977-1978.
    [6] The United States Pharmacopeial Convention.U.S. Pharmacopeia[S]. 39th ed, 2016:3351-3352.
    [7] 国家药典委员会.中华人民共和国药典2015年版四部[S].北京:中国医药科技出版社,2015:374-377.
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Assay of cyproheptadine hydrochloride and the related substances with HPLC

doi: 10.3969/j.issn.1006-0111.2017.01.014
  • Changzhou Siyao Pharm, Changzhou City, Changzhou 213004, China
  • Received Date: 2016-09-03
  • Rev Recd Date: 2016-10-14

Abstract: Objective To establish a HPLC method for the assay of cyproheptadine hydrochloride and the related substances. Methods The HPLC was performed on an Agilent Eclipse XDB-C18 column (4.6 mm×250 mm, 5 μm) at the temperature of 25℃ with the mobile phase of acetonitrile-buffer Solution (Dissolve 2.16 g of sodium octane-1-sulfonate with about 500 ml of water and mix well. Add 10.0 ml of glacial acetic acid and 5.0 ml of triethylamine, and dilute with water to 1 000 ml, mix well and adjust to pH 7.0 with triethylamine) (85:15,V/V). The flow rate was 1.0 ml/min and detection wavelength was 286 nm. The injection volume was 10 μl. Results The calibration curves of cyproheptadine hydrochloride, impurity A, B and C showed good linear response in the range from 0.056 2 to 5.620 μg/ml (r=0.999 8), 0.052 4 to 5.240 μg/ml(r=1.000 0),0.050 3 to 5.032 μg/ml (r=0.999 9) and 0.053 2 to 5.316 μg/ml(r=0.999 8) respectively. The LOQs for cyproheptadine hydrochloride, impurity A, B and C were within 0.049-0.054 μg/ml, LODs were within 0.019-0.022 μg/ml with recovery between 98%-100%. RSD of repeatability was 5.5% (n=6). Conclusion This method gave an accurate and reliable results. It can be used for quality control of cyproheptadine hydrochloride.

WU Heqin, CHEN Zhaoxia. Assay of cyproheptadine hydrochloride and the related substances with HPLC[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 60-63,69. doi: 10.3969/j.issn.1006-0111.2017.01.014
Citation: WU Heqin, CHEN Zhaoxia. Assay of cyproheptadine hydrochloride and the related substances with HPLC[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 60-63,69. doi: 10.3969/j.issn.1006-0111.2017.01.014
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