Validation of a TLC-densitometric method for quality control of Estradiol valerate in drug combinations

The aim of the current study was the validation of a TLC-densitometric method for quality control of Estradiol valerate in drug combination dosage forms. The TLC conditions were: glass plates with silicagel G(60)F(254); mobile phase: chloroform : water = 90 : 10 v/v. The TLC-densitometric method was validated with respect to the analytical parameters: limearity, LOD, LOQ, accuracy and precision (repeatability). Linear regression analysis was performed. The regression calibration curve was built. Linearity accordance between the concentration and spot area in range: 5.10(-4) g/ml divided by 3.10(-3) g/ml was proved by the regression equation: y = 28874286.x + 14290. LOD = 3.15.10(-4) mg/ml; LOQ = 9.54.10(-3) mg/ml. For estimating the accuracy the recovery is presented in R [%] +/- RSD [%] with the respective confidence interval: R[1.5 mg]: 95.92 % divided by 103.98 %; R[2 mg]: 93.35 % divided by 108.89 %; R[2.5 mg]: 95.37 % +/- 103.77 %. Precision is estimated by standard deviation, relative standard deviation and confidence interval. All data for the obtained quantity correspond to the confidence interval: 1.88 mg divided by 2.17 mg. The proposed. validated TLC-densitometric method is appropriate for quality control of Estradiol valerate in commercially available tablets.