Validation of TLC – densitometric method for identification and determination of Estradiol

personАвтори: D. Tsvetkova, K. Ivanov, St. Ivanova, St. Pankova, St. Papanov

Abstract

The aim of current study was the validation of TLC densitometric method for identification and determination of Estradiol hemihydrate in dosage forms. The TLC conditions were: glass plates with Silicagel G60F254; mobile phase:chloroform : water  = 90 : 10 v/v. Linearity accordance between ther concentration and spot area in range: 5.10-4g/ml ¸ 5.10-3g/ml is proved by the regression equation: y = 53256970.x – 7007. The results of the recovery studies presented in R [%] ± RSD [%] suit respective confidence interval: 1) RС1.5: 98.75 % ¸ 102.13 % (SD = 1.01); 2) RС2: 98.73 % ¸ 102.93 % (SD = 1.25); 3) RС2.5: 98.29 % ¸ 103.03 % (SD = 1.4). All data for the obtained quantity of Estradiol hemihydrate correspond to the confidence interval: 1.95 mg ¸ 2.09 mg (SD = 0.05).The proposed validated TLC densitometric method is appropriate for quality control of Estradiol hemihydratein commercially available tablets.

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