V. Sreeram

A simple, selective, linear, precise and accurate UPLC Method was developed and validated for rapid assay of Nordette in tablet Formulation. Isocratic elution at a flow rate of 0.4ml/min was employed on C8 1.7 µm (2.1 mm x 100 mm) Column at ambient temperature40 °C. Injection Volume was found to be 5.0 µl. The mobile phase consisted of Acetonitrile : Water  60:40 v/v which is filter through a 0.2 µm filter The UV detection wavelength was 220nm and 2µl sample was injected. The retention time for Ethinylestradiol, Levonorgestrel is found to be ± 1.4 minutes and ± 2.1 minutes respectively. A linear regression curve was constructed, and the correlation coefficients (R2) and assessment values calculated. The percentage RSD for both Ethinylestradiol, Levonorgestrel was found to be 1.5%.The Accuracy of method ranges between 97.0 – 102.8%.  The method was validated as per the ICH guidelines. The method was successfully applied for routine quality control analysis of pharmaceutical formulation.