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. 2010 Jan;72(1):119-22.
doi: 10.4103/0250-474X.62252.

A new stability indicating HPLC method for related substances in zolmitriptan

E K S Vijayakumar  1 , M A Samel, S B Bhalekar, S M Pakhale
Affiliations

A new stability indicating HPLC method for related substances in zolmitriptan

E K S Vijayakumar et al. Indian J Pharm Sci. 2010 Jan.

Abstract

A sensitive, precise, specific, linear and stability indicating isocratic HPLC method was developed for the analysis of related substances in zolmitriptan. The potential known related substances are (S)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one (impurity I) and (S)-4-(4-hydrazinobenzyl)-1,3-oxazolidin-2-one (impurity II). The method can be used for the detection and quantification of known and unknown impurities and degradants in the drug substance zolmitriptan during routine analysis and also for stability studies in view of its capability to separate degradation products.

Keywords: Forced degradation; HPLC; method development; related substances; zolmitriptan.

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Figures

Fig. 1
Fig. 1
Chemical structures of zolmitriptan and impurities I and II Zolmitriptan: (S)-4-{[3-(2-dimethylaminoethyl)-1H-indol-5-yl] methyl}-1,3-oxazolidin-2-one; Impurity I: (S)-4-(aminobenzyl)-1,3-oxazolidin-2-one; Impurity II: (S)-4-(4-hydrazinobenzyl)-1,3-oxazolidin-2-one.
Fig. 2
Fig. 2
Chromatogram of a mixture of zolmitriptan and impurities I-II at LOD level Peak at tR: 4.722 min is due to impurity I (LOD: 50 ng/ml); Peak at tR: 14.638 min is due to zolmitriptan (LOD: 50 ng/ml); Peak tR: 27.548 min is due to impurity II (LOD: 200 ng/ml).
Fig. 3
Fig. 3
Chromatogram of a mixture of zolmitriptan and impurities I-II at LOQ level Peak at tR: 4.721 min is due to impurity I (LOQ: 150 ng/ml); Peak at tR: 14.645 min is due to zolmitriptan (LOQ: 150 ng/ml); Peak tR: 27.568 min is due to impurity II (LOQ: 600 ng/ml).
Fig. 4
Fig. 4
Chromatogram of a zolmitriptan sample Peak at tR: 4.482 min is due to impurity I; Peaks at tR: 4.977, 11.273, 12.402, 13.923, 26.253, 28.696 and 33.780 min are due to unknown impurities; Peak at tR: 9.421 min is due to zolmitriptan.
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