Sonia Talaat Hassib1 Elham Anwer Taha2 Eid Mohammed Messalam2* 1- Pharmaceutical Chemistry Department, Faculty of pharmacy, Cairo University, Kaser El- Eini Street, 11562 Cairo, Egypt. 2- National Organization for Drug Control and Research (NODCAR), 6 Abou Hazem St, Pyramids Avenue; P.O. Box 29 Giza, Egypt.
Summary:A thin-layer chromatographic method has been developed and validated for simultaneous determination of three binary mixtures. Betamethasone valerate was found with clioquinol in mixture (I) and with fusidic acid in mixture (II), while mixture (III) contains hydrocortisone acetate with fusidic acid. For achieving good separation, developing systems consisting of methanol:chloroform (9:1 v/v) for mixture (I) and methanol:chloroform (0.5:9.5, v/v) for mixtures (II) and (III) were chosen. The densitometric determination of each drug was carried at wavelengths, 240, 282, 245 and 253 nm for betamethasone valerate, clioquinol, fusidic acid and hydrocortisone acetate, respectively. The calibration curves were valid over the concentration range of 1-42 µg/spot and 2–65 µg/spot for betamethasone valerate and clioquinol in mixture (I) and 1-45 µg/spot, 5-50 µg/spot and 5–60 µg/spot for betamethasone valerate, hydrocortisone acetate and fusidic acid in mixtures (II) and (III), respectively. The methods were validated according to USP guidelines. The proposed methods were successfully applied for the simultaneous determination of these compounds in their laboratory prepared mixtures and drug products with good accuracy and precision. The results obtained were statistically compared with those obtained by the official ones. |
