Validated HPTLC method for simultaneous estimation of ethinyl estradiol and drospirenone in bulk drug and formulation

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of ethinyl estradiol and drospirenone as bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene/methanol/ammonia (8:2:0.1) (v/v/v). Densitometric evaluation of the separated zones was performed at 280 nm. The two drugs were satisfactorily resolved with Rf values of 0.29±0.02 and 0.42±0.02 for ethinyl estradiol and drospirenone, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (150–400 ng/spot for ethinyl estradiol and 30–80 ng/spot for drospirenone), precision (intraday RSD 0.84–1.01% and interday RSD 0.76–1.04% for ethinyl estradiol, and intraday RSD 0.76–1.32% and interday RSD 0.73–1.01% for drospirenone), accuracy (98.48±0.21% for ethinyl estradiol and 98.30±0.15% for drospirenone), and specificity, in accordance with International Conference on Harmonisation (ICH) guidelines.

Abstract licence: CC BY

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