Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC ASSAY METHOD FOR DETERMINATION OF LEVONORGESTREL IN TABLET FORM

Chinta Srinivasa Reddy* and Naresh Kumar Katari

ABSTRACT

A simple, sensitive and accurate isocratic reverse phase high performance liquid chromatography method was developed for determination of Levonorgestrel in tablets. The effective separation was achieved on Agilent Eclipsed XDB C18 4.6 X 150 mm with particle size 3.5μm. The mixture acetonitrile and DI water in the ratio 70:30 v/v used as a mobile phase. The flow rate of the mobile phase was 1.5 mL/min and the total elution time was 6 minutes. The UV detection wavelength has been carried at 245 nm and experiments were conducted at 40°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, robustness and sample stability for Levonorgestrel following the ICH guidelines.

Keywords: Levonorgestrel tablets, Method development, Eclipsed XDB C18 and RP-HPLC.


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