A.V.D.Nagendrakumar

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method is developed and validated for the estimation of Dapsone in tablet dosage form. The expected separation and peak shapes were obtained on Luna C18, 15 cm x 4.6 mm (5 μm)  column. To have an ideal separation of the drug under isocratic conditions, mixtures of solvents like methanol and water with or without different buffers indifferent combinations were tested as mobile phases on a Luna C18, 15 cm x 4.6 mm (5 μm) column. A mixture of Methanol:Water in the ratio of 40:60 v/v was proved to be the most suitable of all the combinations since the chromatographic peak obtained was better defined and resolved and almost free from tailing.  The flow rate was 1.0ml/min and effluents were monitored at 260 nm. The retention time for Dapsone was ± 2.4 min. The method was validated for accurate, precise, simple, sensitive and rapid and can be applied successfully for the estimation of Dapsone in bulk and in pharmaceutical formulations without interference and with good sensitivity. And recovery of Dapsone from tablet formulation was found to be 93%. The proposed method was successfully applied for the quantitative determination of Dapsone in tablet formulation.

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.