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Abstract
This paper describes a strategic development and validation of stability-indicating high-performance liquid chromatography (HPLC) method for the determination of potential impurities present in highly potent and low dose combination drug product of Norgestimate and Ethinyl estradiol tablets. Effective and faster separation of impurities from the drug products was achieved on a sub-2 µm fused core particle C8 column (150 mm × 4.6 mm i.d.) using water and acetonitrile as mobile phase in gradient pump mode. Flow rate was selected 1.0 mL/min with a detection quantification wavelength of 230 nm. The calibration curve obtained from linearity data (r > 0.995) in the relevant ranges (up to 150% of the expected concentration of the analytes in the test concentration), accuracy (>95% recovery for the impurities of respective analytes), method precision and intermediate precision (RSD < 5.0%), specificity (purity is less than purity threshold for all potential impurities present in respective drug components), and method robustness parameters were evaluated, and system suitability parameters were determined. The validated HPLC method was successfully applied to the quantification of impurities in Norgestimate and Ethinyl estradiol tablets helping to improve quality control and to assure therapeutic efficacy.