Development and Validation of a TLC-Densitometry Method for Assay of Estradiol Hemihydrate in Tablets
Małgorzata Dołowy, Anna Kurowska and Alina Pyka
AbstractA simple, rapid and cost-effective NP-TLC method combined with densitometry was developed for determination of estradiol hemihydrate in tablet dosage form. TLC-densitometric analysis was conducted on silica gel 60F254 plates. Benzene + methanol in volume composition 9:1 was used as a mobile phase. The detection was carried out at 200 nm. Applied chromatographic conditions enabled complete separation of estradiol hemihydrate (EL) from its related substance, namely estrone (EN) with simple procedure of sample preparation. Linearity range for estradiol hemihydrate was from 0.50 to 1.50 g/spot. The detection limit (LOD) and quantitative limit (LOQ) values of estradiol hemihydrate were 0.14 g/spot and 0.41 g/spot, respectively. The developed method was found to be precise, accurate, and robust. The assay value of estradiol hemihydrate was consistent with the limit recommended by Pharmacopoeia. The elaborated TLC-densitometric method can be used as an alternative method for the accurate assay of estradiol hemihydrate in tablet dosage form because it fulfills the validation criteria of an analytical method designated for quantity control of pharmaceutical preparations.
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