JOURNAL OF LIAONING TECHNICAL UNIVERSITY

Analytical method development with validation of bulk drug – dutasteride employing relative impurity profile.

Balaji R1, B. Babu*, Gowtham G. P, Nadimpalli prudhvi varma, C. Reethu Sree, Vinay B, Ramesh J.

ABSTRACT: Benign prostatic hyperplasia is currently treated with the drug dutasteride. Similar to the finasteride, nearly 50 % of serum prostate specific antigen is reduced at the period of 6 months and having a 25 % of prostate volume in 2 years. The aim of this study is to develop a new analytical method with RP-HPLC (Reverse Phase High Performance Liquid Chromatography) which is highly accurate and new precise method for analyzing the purity of dutasteride as both in pharmaceutical formulation and in bulk quantities. As stated, in this study a new method was developed and validated for analyzing dutasteride in oral dosage form, by using RP-HPLC. 30 % of 0.02M phosphate buffer with 70 % acetonitrile (30:70 v/v) ratio is used as mobile phase in Zorbax SB C18 (5 µm) having a diameter of 250 x 4.6 mm with a flow rate of 1.2 ml/min, and optimized wavelength of 225 nm. ICH guidelines were used to validate the method. Results of assay for impurity in bulk drug were in allowable limit as per ICH. The proposed data conclude that the studies carried out, shows the development of analytical method and validation of dutasteride bulk drug employing relative impurity profile.

Keywords: Dutasteride, RP-HPLC. impurity profile, ICH, Method development