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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: 564 times Total Downloads: 268 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]

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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”.

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