Title:Validated RP-TLC Method with Densitometry for Assay of Finasteride in Simple Pharmaceutical Dosage Form
VOLUME: 14 ISSUE: 3
Author(s):Malgorzata Dolowy*, Agata Piontek and Alina Pyka-Pajak
Affiliation:Department of Analytical Chemistry, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Student Research Group at the Department of Analytical Chemistry, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Department of Analytical Chemistry, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Katowice
Keywords:Finasteride, steroids, chromatography, RP-TLC, densitometry, validation.
Abstract:Background: Finasteride is a medically important compound belonging to 4-azasteroids
which are widely used in the treatment of benign prostatic hypertrophy. Therefore, there is a need to
find a simple, cost effective and sensitive method for the determination of finasteride in commercially
available tablet dosage form.
Objective: To develop and validate a rapid and simple RP-TLC method combined with densitometry for
the quantification of finasteride in tablet dosage form containing 5 mg of active substance alone.
Method: Chromatographic analysis was performed on aluminum plates precoated with silica gel 60
RP18F254 using mobile phase consisting of 1,4-dioxane-water in volume composition 35:15. Densitometric
scanning was done in the absorbance mode at 212 nm. Validation of proposed RP-TLC method
was carried out according to the ICH guidelines.
Results: Validation data indicated that the proposed RP-TLC method was accurate and precise with
coefficient of variation CV, to be less than 2% in both cases. The method was linear over the range of
1.00÷4.00 µg/spot with correlation coefficient equal to 0.9981. The LOD and LOQ were found to be
0.24 and 0.74 µg/spot, respectively. Assay results of finasteride in marketed tablets using this method
were in agreement with label claim and also with pharmacopoeial requirements.
Conclusion: A new, simple and economical RP-TLC method with densitometry developed in this study
can be found to be suitable for routine analysis of finasteride in simple tablet dosage form containing
this active substance.
