Development and validation of stability indicatingRP-HPLC method for the simultaneous estimation of Ethinyl estradiol and Gestodene in bulk and pharmaceutical dosage forms
A simple, new, rapid, selective, precise and economic stability indicating method was developed and validated by RP-HPLC method for the simultaneous estimation of Estradiol and Gestodene in bulk and pharmaceutical dosage forms. The present method was developed and validated on Waters HPLC system using Phenomenex Gemini C18(250mm × 4.6mm i.d, 5µm particle size) column and mobile phase composition of Acetonitrile and phosphate buffer (25:75 v/v, pH 3.6). The system was regulated at 1.0ml/min flow rate for total 8 minutes run time at 237nm UV detection. The two drugs Ethinyl Estradiol and Gestodene were eluted at 1.788min and 3.475min respectively. The analytical parameters such as accuracy, precision, linearity, LOD, LOQ, ruggedness and robustness were used for validating the developed methodology as guidelines stated in International Conference on Harmonisation (ICH). Linearity was exhibited over the concentration range of 10-50µgm/ml and 25-125µgm/ml for Ethinyl Estradiol and Gestodene respectively. The method revealed the Limit of Detection and Limit of Quantitation values for Ethinyl Estradiol and Gestodene were 1.399µgm/ml, 3.909µgm/ml and 4.24µgm/ml, 11.85µgm/ml respectively. The stress testing was carried out to give rise to degradation products by exposing the drugs to acid, alkali, thermal, oxidative and photolytic degradation. The obtained data showed that the degraded products were successfully separated from the drug compounds indicating the stability indicating nature of the developed method. Hereupon, the developed method perhaps satisfactorily applied for the periodic laboratory quantitative estimation of Ethinyl Estradiol and Gestodene in formulations and active pharmaceutical ingredients.
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