Abstract
Objective: The principal objective of this study is to develop and validate a simple, new, fast, selective, precise, and economic stability-indicating the RP-HPLC method for the simultaneous estimation of Ethinyl estradiol and Gestodene in a bulk and pharmaceutical dosage form.
 Methods: The present method was developed and validated on a Waters HPLC system using Phenomenex Gemini C18(250 mm × 4.6 mm i.d., 5 µm particle size) column and mobile phase composition of phosphate buffer: Acetonitrile (75:25 v/v) and the pH was adjusted to 3.6 using dilute orthophosphoric acid. The system was regulated at 1.0 ml/min flow rate at 237 nm UV detection.
 Results: The two drugs Ethinyl Estradiol and Gestodene, were eluted at 1.788 min and 3.475 min retention time, respectively. The analytical parameters such as accuracy, precision, linearity, LOD, LOQ, ruggedness, and robustness were used for validating the developed method according to International Conference on Harmonisation [ICH] guidelines. Linearity was exhibited over the concentration range of 10-50µg/ml and 25-125µg/ml for Ethinyl Estradiol and Gestodene, respectively. The method revealed the Limit of Detection and Quantitation values for Ethinyl Estradiol and Gestodene were 1.399µg/ml, 3.909µg/ml and 4.24µg/ml, 11.85µg/ml, respectively. The stress testing was carried out to give rise to degradation products by exposing the drugs to acid, alkali, thermal, oxidative, photolytic, and hydrolytic degradation. The obtained data showed that the content of Active pharmaceutical ingredients and the degradation products were successfully separated without any interference, which confirmed the stability-indicating nature of the developed method.
 Conclusion: The new, simple, rapid, selective, precise, and economic stability-indicating RP-HPLC method has been successfully developed and validated. It can be satisfactorily applied for the periodic laboratory quantitative estimation of Ethinyl Estradiol and Gestodene in formulations and active pharmaceutical ingredients.
Highlights
Ethinyl Estradiol is chemically (8R,9S, 13S, 14S, 17R)-17-ethynyl-13methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a] phenanthrene -3,17-diol [fig. 1], an estrogen drug is used widely in birth control pills in combination with progestins
Various mobile phases tried were water: methanol, Water: Acetonitrile, Phosphate buffer: Methanol, Phosphate buffer: Acetonitrile by varying proportions and at last, the Phosphate buffer: Acetonitrile (75:25 v/v) and the pH was adjusted to 3.6 using dilute orthophosphoric acid by maintaining the system at 1.0 ml/min flow rate at 237 nm UV detection was finalized as optimal
The optimized chromatogram of Ethinyl estradiol and Gestodene was displayed in fig. 3 and resulted in table 1
Summary
Ethinyl Estradiol is chemically (8R,9S, 13S, 14S, 17R)-17-ethynyl-13methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a] phenanthrene -3,17-diol [fig. 1], an estrogen drug is used widely in birth control pills in combination with progestins. Ethinyl Estradiol is chemically (8R,9S, 13S, 14S, 17R)-17-ethynyl-13methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a] phenanthrene -3,17-diol [fig. It is used to treat menopausal symptoms, gynecological disorders, and certain hormone-sensitive cancers [1]. Ethinyl estradiol binds to the estrogen receptor complex, enters the nucleus, and activates the DNA transcription process. It prevents ovulation by decreasing luteinizing hormone, which in turn decreases endometrial vascularization and decreases gonadotrophic hormone. In epididymal tissue, it lowers testosterone levels and prevents prostatic cancer by inhibiting the 5-alpha reductase enzyme. It is used for osteoporosis [2]
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