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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR ESTIMATION OF TIGECYCLINE IN BULK AND ITS PARENTERAL DOSAGE FORMS

Dr. A. Suneetha*, G. Hari Priyanka and J. Sujitha

ABSTRACT

The present method describes the development of a validated RP-HPLC method for determination of Tigecycline. Separation was carried out on a Kromasil ODS C-18 column (150×4.6mm, 5μ) using Buffer: Acetonitrile 83: 17 as mobile phase at a flow rate of 1.2 ml/min. UV detection was performed at 247nm. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision and robustness. The assay method was found to be linear in the range of 80 to 120 μg/ml with a correlation coefficient of 0.9999. The percentage recovery of active pharmaceutical ingredient from parenteral dosage form ranged from 99.5 to 100.2%. The results showed that the developed RP-HPLC method is suitable for determination of Tigecycline in bulk as well as stability samples of pharmaceutical dosage forms containing various excipients.

Keywords: High performance liquid chromatography, Tigecycline, Validation, Peak Area.


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