Welcome to visit Zhongnan Medical Journal Press Series journal website!
Zhongnan Medical Journal Press Series of Journals Center for Evidence-Based and Translational Medicine of Wuhan University

The title
  • The title
  • The keywords
  • The author
Submit
Home Articles Vol 26,2023 No.12 Detail

Determination of related substances of zolmitriptan tablets by HPLC and study of quality evaluation

Published on Jan. 24, 2024Total Views: 1102 times Total Downloads: 393 times Download Mobile

Author: Hai-Ling SUN 1 Shi BAO 2 Qian ZHOU 1 Ying SUN 1 Jing YANG 1 Lei-Ling CHEN 1 Chen-Xi LIU 1

Affiliation: 1. Hubei Institute for Drug Control, Wuhan 430075, China 2. Hubei Engineering Research Center for Drug Quality Control, Wuhan 430075, China

Keywords: Zolmitriptan tablets High performance liquid chromatography Related substances Quality control Consistency evaluation of generic drugs

DOI: 10.12173/j.issn.1008-049X.202304118

Reference: Hai-Ling SUN, Shi BAO, Qian ZHOU, Ying SUN, Jing YANG, Lei-Ling CHEN, Chen-Xi LIU.Determination of related substances of zolmitriptan tablets by HPLC and study of quality evaluation[J].Zhongguo Yaoshi Zazhi,2023,26(12):519-526.DOI: 10.12173/j.issn.1008-049X.202304118.[Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Objective  To evaluate the quality of zolmitriptan tablets, establish an HPLC method for the determination of related substances in zolmitriptan tablets, improve the quality standard, and provide technical support for drug regulation.

Methods  The Superlco Ascentis Express90 Phenol Hexy chromatography column (10 cm×3.0 mm, 2.7 μm) was recommended. The mobile phase was phosphate buffer containing sodium hexanesulfonate (pH 2.0)-acetonitrile, with gradient elution. The detection wavelength was 220 nm, the flow rate was 0.8 mL·min-1, the column temperature was 40 ℃, and the injection amount is 10 μL. The method was used to test 40 batches of zolmitriptan tablet samples and substance taken from all over the country.

Results  Zomitriptan had a goog linear relationship in the range of 0.840-1.260 μg·mL-1 (r=0.999 9), and its detection limit was 1 ng. The detection limits for impurities 1-5 were 0.11, 0.52, 10.91, 1.04 and 2.18 ng, respectively.

Conclusion  The method is specific, and was used to evaluate the quality of commercially available zolmitriptan tablets. The critical control points and the effect of coating technology on the quality of zolmitriptan tablets were found, and it is suggested that the storage condition of the product should be defined as “cool and dark place”.

Full-text
Please download the PDF version to read the full text: download
References

1.刘唯, 陆佳洁, 郭效宁, 等. 丛集性头痛发作前驱期口服佐米曲普坦的疗效和安全性[J]. 徐州医科大学学报, 2023, 43(3): 201-204. [Liu W, Lu JJ, Guo XN, et al. Effectiveness and safety of oral zolmitriptan in the prodromal phase of cluster headache[J]. Acta Academiae Medicinae Xuzhou, 2023, 43(3): 201-204.] DOI: 10. 3969/j.issn.2096-3882.2023.03.009.

2.耿彪, 于焕君, 党和勤, 等. 治疗偏头疼新型非口服药物研究进展[J]. 中国疼痛医学杂志, 2022, 28(10): 765-769. [Gen B, Yu HJ, Dang HQ, et al. Research progress of new non-oral drugs for migraine[J]. Chinese Journal of Pain Medicine, 2022, 28(10): 765-769.] DOI: 10.3969/j. issn.1006-9852.2022.10.08.

3.赵刚, 苏庆, 李静, 等. 治疗偏头痛药佐米曲普坦制剂的研究进展[J]. 中国新药杂志, 2007, 16(11): 836-839. [Zhao G, Su Q, Li J, et al. Research progress of migraine zolmitriptan[J]. Chinese Journal of New Drugs, 2007, 16(11): 836-839.] DOI: 1003-3734(2007)11-0836-04.

4.符乃光, 陈袆平. 佐米曲坦的Fischer吲哚环合工艺改进[J]. 化学试剂, 2008, 30(11): 865-866. [Fu NG, Chen HP. Improved Fischer indole cyclization of zolmitriptan[J]. Chemical Reagents, 2008, 30(11): 865-866.] DOI: 0258-3283(2008)11-0865-02.

5.中国药典2020年版. 二部[S]. 2020: 506.

6.USP42[S]. 2019: 4261-4268.

7.EP10.0[S]. 2020: 4251-4252.

8.石杰, 史犇, 吴拥军, 等. HPLC测定佐米曲普坦片的含量[J]. 华西药学杂志, 2007, 22(5): 588-589. [Shi J, Shi B, Wu YJ, et al. Determination assay of zolmitriptan by HPLC[J]. West China Journal of Pharmaceutical Sciences, 2007, 22(5): 588-589.] DOI: 1006-0103(2007)05-0588-02.

9.Srinivasu MK, Rao BM, Sridhar G, et al. A validated chiral LC method for the determination of Zolmitriptan and its potential impurities[J]. J Pharm Biomed Anal, 2005, 37(3): 453-60. DOI: 10.1016/j.jpba.2004.10.021.

10.Douša M, Gibala P, Rádl S, et al, Identification, preparation and UHPLC determination of process-related impurity in zolmitriptan[J]. J Pharm Biomed Anal, 2012, 58: 1-6. DOI: 10.1016/j.jpba.2011.08.043.

11.Reddy AVB, Venugopal N, Madhavi G, et al. A selective and sensitive UPLC-MS/MS approach for trace level quantification of four potential genotoxic impurities in zolmitriptan drug substance[J]. J Pharm Biomed Anal, 2013, 84: 84-89. DOI: 10.1016/j.jpba.2013.05.047.

12.Zhang ZJ, Xu FG, Tian Y, et al. Quantification of zolmitriptan in plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2004, 813(1-2): 227-233. DOI: 10.101.1016/j. jchromb.2004.09.043.

13.张姮婕, 江燕, 张丹, 等. HPLC测定佐米曲普坦中的有关物质[J]. 华西药学杂志, 2012, 27(6): 712-714. [Zhang HJ, Jiang Y, Zhang D, et al. Determination related substances in zolmitriptan by HPLC[J]. West China Journal of Pharmaceutical Sciences, 2012, 27(6): 712-714.] DOI: CNKI:SUN:HXYO:0.2012-06-039.

14.阎平, 冯翠玲, 谢剑. HPLC法测定佐米曲普坦的含量及有关物质[J]. 中国药物应用与监测, 2004, 2(2): 31-32. [Yan P, Feng CL, Xie J. Determination the related substances and assay of zolmitriptan by HPLC[J]. Chinese Journal of Drug Application and Monitoring, 2004, 2(2): 31-32.] DOI: 10.3969/j.issn.1672-8157.2004.02.012.

15.Vijayakumar EKS, Samel MA, Bhalekar SB, et al. A new stability indicating HPLC method for related substances in zolmitriptan[J], Ind J Pham Sci, 2010, 72(1): 119-122. DOI: 10.4103/0250-474X.62252.

16.Rao BM, Srinivasu MK, Sridhar G, et al. A stability indicating LC method for zolmitriptan[J]. Pharm Biomed Anal, 2005, 39(3-4): 503-509. DOI: 10.1016/j.jpba.2005. 04.018.

Popular papers
Last 6 months