Ultra Performance Liquid Chromatographic Method Development And Validation Of Ethinyl Estradiol And Norgestimate

Abstract

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-UPLC method for the simultaneous measurement of active pharmaceutical ingredients of Norgestimate and Ethinyl Estradiol.

Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-UPLC methodology for the simultaneous determination of Norgestimate and Ethinyl Estradiol. The chromatographic strategy utilized Phenyl column of dimensions 50x2.1 mm, 1.7 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% Tri fluoro acetic acid (50:50). A flow rate of 0.5 ml/min and a detector wavelength of 255 nm utilizing the PDA detector were given in the instrumental settings.

Results: LOD and LOQ for the active ingredient were established with respect to test concentration. The calibration chart plotted was linear with a regression coefficient of R² > 0.999, means the linearity was within the limit. Specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.