Development of a New Analytical Method for Determination of Related Components in Nateglinide |
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Authors: | A Madhavi G S Reddy M V Suryanarayana A Naidu |
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Institution: | (1) Dr.Reddy’s Laboratories, Active Pharmaceutical Ingredients, Unit-III, Bollaram, Hyderabad, 502 325, India;(2) Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, 500 072, India |
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Abstract: | An isocratic reverse phase liquid chromatographic (RP-LC) assay method has been developed for the quantitative determination
of nateglinide and its related components namely imp-1 and imp-2 in bulk drug and in pharmaceutical dosage form, used for
the treatment of type II diabetes mellitus. The developed method is stability indicating and also can be used for stability
testing. The chromatographic separation was achieved on C-8, 150 × 4.6 mm, 3.5 μm stationary phase. The LC method employs
solution A as mobile phase. Solution A contains a mixture of phosphate buffer pH 3.0: acetonitrile (50:50 v/v). The flow rate was 1.0 mL min−1 and the detection wavelength was 210 nm. In the developed LC method the resolution between nateglinide and its potential impurities
namely imp-1 and imp-2 was found to be greater than 5.0. The drug was subjected to stress conditions of hydrolysis, oxidation,
photolysis and thermal degradation. Considerable degradation was found to occur in acid medium, alkaline medium and oxidative
stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close
to 99.2%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness. |
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Keywords: | Column liquid chromatography Forced degradation Validation and stability indicating Nateglinide |
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