Quantitative analysis of cyproterone acetate and ethinylestradiol in tablets by use of planar chromatography

Abstract

This paper describes a simple, rapid, and reliable HPTLC procedure for the determination of cyproterone acetate and ethinylestradiol in tablets. Identification and determination were performed on 10 cm x 20 cm, LiChrospher silica gel 60 F-254 HPTLC plates with cyclohexane-ethyl acetate, 6 + 4 (nu/nu), as mobile phase. Calibration plots were established showing the dependence of response (peak area) on amount chromatographed. The ranges validated were 250-4000 ng (r = 0.9923) and 100-500 ng (r = 0.9996) for cyproterone acetate and ethinylestradiol, respectively. The suitability of this HPTLC method for quantitative determination of the compounds was proved by validation of precision and accuracy. The method was used for determination of the compounds in commercial pharmaceutical dosage forms (Androcur 10 mg and Diane 35 tablets). The method is simple, reproducible, and accurate and can be used as a more effective option than other chromatographic techniques in routine quality control.