Stability-indicating HPLC assay method of zomepirac

Chau Yang Chen, Fu A. Chen, Chih J. Chen, Kun Shan Wu, An Bang Wu

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

An HPLC assay method for determining the degradation of zomepirac was developed and validated under acidic, basic, and photo-irradiated conditions. The HPLC system consisted of an Inertsil 5 ODS-3V column (4.6 × 250 mm i.d.), and a guard column of Inertsil 7 ODS-3V (4.6 × 50 mm i.d.) using a mobile phase of CH3CN: CH3OH: 1%HOAc (2:64:34, v/v/v) with UV detection at 254 nm. The developed method satisfies the system suitability criteria, peak integrity, and resolution for the parent drug and its degradants. The results indicate that the established assay method shows good selectivity and specificity suitable for stability measurements of zomepirac. From the intra- and interday tests of 6 replicates, the coefficients of variations (CVs) were between 0.12% and 2.24% for the former and 0.15% and 3.93% for the latter. Recoveries were found to be between 97.14% and 101.58%. From the stress treatments, zomepirac was determined to be more sensitive to the light and acidic conditions, but it was stable in basic medium. A preliminary kinetic study of the photodegradation of zomepirac in methanol showed that it followed an apparent first-order reaction.

Original languageEnglish
Pages (from-to)87-91
Number of pages5
JournalJournal of Food and Drug Analysis
Volume11
Issue number2
Publication statusPublished - Jun 2003

Fingerprint

High Pressure Liquid Chromatography
assays
photolysis
Photolysis
methanol
methodology
Methanol
kinetics
drugs
degradation
Light
zomepirac
testing
Pharmaceutical Preparations

Keywords

  • HPLC
  • Photodegradation
  • Zomepirac

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

Cite this

Chen, C. Y., Chen, F. A., Chen, C. J., Wu, K. S., & Wu, A. B. (2003). Stability-indicating HPLC assay method of zomepirac. Journal of Food and Drug Analysis, 11(2), 87-91.

Stability-indicating HPLC assay method of zomepirac. / Chen, Chau Yang; Chen, Fu A.; Chen, Chih J.; Wu, Kun Shan; Wu, An Bang.

In: Journal of Food and Drug Analysis, Vol. 11, No. 2, 06.2003, p. 87-91.

Research output: Contribution to journalArticle

Chen, CY, Chen, FA, Chen, CJ, Wu, KS & Wu, AB 2003, 'Stability-indicating HPLC assay method of zomepirac', Journal of Food and Drug Analysis, vol. 11, no. 2, pp. 87-91.
Chen CY, Chen FA, Chen CJ, Wu KS, Wu AB. Stability-indicating HPLC assay method of zomepirac. Journal of Food and Drug Analysis. 2003 Jun;11(2):87-91.
Chen, Chau Yang ; Chen, Fu A. ; Chen, Chih J. ; Wu, Kun Shan ; Wu, An Bang. / Stability-indicating HPLC assay method of zomepirac. In: Journal of Food and Drug Analysis. 2003 ; Vol. 11, No. 2. pp. 87-91.
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N2 - An HPLC assay method for determining the degradation of zomepirac was developed and validated under acidic, basic, and photo-irradiated conditions. The HPLC system consisted of an Inertsil 5 ODS-3V column (4.6 × 250 mm i.d.), and a guard column of Inertsil 7 ODS-3V (4.6 × 50 mm i.d.) using a mobile phase of CH3CN: CH3OH: 1%HOAc (2:64:34, v/v/v) with UV detection at 254 nm. The developed method satisfies the system suitability criteria, peak integrity, and resolution for the parent drug and its degradants. The results indicate that the established assay method shows good selectivity and specificity suitable for stability measurements of zomepirac. From the intra- and interday tests of 6 replicates, the coefficients of variations (CVs) were between 0.12% and 2.24% for the former and 0.15% and 3.93% for the latter. Recoveries were found to be between 97.14% and 101.58%. From the stress treatments, zomepirac was determined to be more sensitive to the light and acidic conditions, but it was stable in basic medium. A preliminary kinetic study of the photodegradation of zomepirac in methanol showed that it followed an apparent first-order reaction.

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