DOI: 10.36347/sajp.2020.v09i02.004

Pages: 75-81

The aim of current study was the application of validated TLC-densitometric method for quality control of pharmaceutical dosage products, containing steroid component Estradiol valerate. The used materials were: Climonorm tabl. CN1 (Estradiol valerate 2 mg); Climonorm tabl. CN2 (Estradiol valerate 2 mg/Levonogestrel 0.15 mg); Climen tabl. CM1 (Estradiol valerate 2 mg); Climen tabl. CM2 tabl. (Estradiol valerate 2 mg/Ciproterone acetate 1 mg). Thin layer chromatographic-densitometric method was applied. The used instrumentation was densitometer VILBER LOURMAT CN-15 LC. Chromatographic system used was: stationary phase: Silicagel G60F254 glass plates; mobile phase: chloroform: acetone = 90: 10 v/v, migration distance of mobile phase: 120 mm, detection at  = 254 nm. The amount of Estradiol valerate in Climonorm tabl. and Climen tabl. was determined by method of calibration curve by using of regression equation: y = 28874286.x + 14290 in concentration range: 5.10–4 g/ml ÷ 3.10–3 g/ml. LOD = 3.15.10-4 g/ml; LOQ = 9.54.10-3 g/ml. Analytical parameter precision (repeatability) is presented by standard deviation (SD) and related standard deviation (RSD) and is proved by the fact that all of the experimental results for the content of Estradiol valerate correspond to the respective confidence interval:  t.S : Climonorm CN1 tabl.: 1.78 mg ÷ 2.1 mg; SD = 0.09; Climonorm CN2 tabl.: 2 mg ÷ 2.16 mg; SD = 0.08; Climen CM1 tabl.: 1.81 mg ÷ 2.13 mg; SD = 0.09; Climen CM2 tabl.: 1.77 mg ÷ 2.09 mg; SD = 0.09. The proposed TLC-densitometric method is appropriate for identification and determination of Estradiol valerate in commercially available tablets.