Validated stability-indicating HPLC method for analysis of gemifloxacin in tablet formulations

• Autorzy: Sharif S , Khan I. U. , Sheikh T. A , Sharif Y , Ashfaq M.
• Języki publikacji: EN

Abstrakty

EN

A stability-indicating reversed-phase high-performance liquid chromatographic method has been developed for analysis of gemifloxacin in tablet formulations. When the drug was subjected to forced degradation under acidic, basic, thermal, oxidative, and photolytic conditions, the degradation products produced were successfully separated on a 250 mm × 4.6 mm, 5-μm particle, C18 column with ammonium acetate buffer (pH 2.7; 0.05 M)-acetonitrile 70:30 (υ/υ) as mobile phase at a flow rate of 0.7 mL min^-1. Diode-array detection was performed at 272 nm. The method was validated in accordance with ICH guidelines. Response was a linear function of concentration over the range 0.256–128 μg mL^-1 (correlation coefficient 0.9990). The limits of detection and quantification were 10 and 30 ng mL^-1, respectively. Separation of gemifloxacin from its stress-induced degradation products and excipients was adequate; resolution was >1.5 within 11 min. The purity index for the gemifloxacin peak after all types of stress was >0.999, indicating complete separation of the analyte peak from the degradation products. The method can therefore be regarded as stability-indicating. It is rapid, and suitable for purity and assay determination not only for routine quality control but also in stability studies.

Słowa kluczowe

EN

HPLC-DAD; stability-indicating method; gemifloxacin; stress-induced; chromatographic purity; degradation product

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2011
• Tom: Vol. 23, no. 1
• Strony: 95--107
• Opis fizyczny: Bibliogr. 22 poz., rys., tab.

Twórcy

autor

Sharif S

• Government College University Materials Chemistry Laboratory, Department of Chemistry Lahore 54000 Pakistan

autor

Khan I. U.

• Government College University Materials Chemistry Laboratory, Department of Chemistry Lahore 54000 Pakistan

autor

Sheikh T. A

• Government College University Materials Chemistry Laboratory, Department of Chemistry Lahore 54000 Pakistan

autor

Sharif Y

• University of Veterinary and Animal Sciences Department of Physiology and Biochemistry Lahore 54000 Pakistan

autor

Ashfaq M.

• University of Gujrat Department of Chemistry, H. H. Campus Gujrat 50700 Pakistan

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