Hygeia journal for drugs and medicines


Development and Validation of a RP- UFLC method for Estimation of synthetic steroid hormone Danazol

Hygeia.J.D.Med.8(1) May 2016 - October 2016  


Shanmugam R*, Kirthi A,  Madhuri K, Ashok Kumar C K, Lalitha Priyanka D

1. Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Tirupati- 517102, India.
2. Department of Pharmaceutics JSS College of Pharmacy, Rocklands, Ooty- 643001, India.

Plan: Danazol is a synthetic steroid hormone with anti-estrogenic and anti-gonadotropic activities drug which acts on anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins indicated for the treatment of endometriosis and benign breast disorders. The main objective of the research work was to develop simple, rapid and sensitive analytical method using RP- UFLC method for estimation of synthetic steroid hormone danazol in bulk and finished formulation.

Methodology: A simple,rapid and sensitive analytical method was developed. Separation of the chromatographic condition was done by using a mobile phase as isocratic flow with the concentration of 25 mM ammonium acetate (pH 4) and acetonitrile at the ratio of 50:50v/v. Flow rate of the mobile phase was maintained at l ml/min.Stationary phase used was C18 column (250 x 4.6 mm). Detection of danazol drug was carried out at 275 nm. The developed method was evaluated for the validation parameters such as specificity,sensitivity, linearity, accuracy, precision, ruggedness and robustness were performed as per the ICH guidelines.

Outcome: An optimized chromatographic condition for danazol drug was achieved and results showed good peak resolution. The developed method for the danazol can be used for the quantitative and qualitative estimation of bulk and finished formulations 

Keywords: Danazol, ICH, Validation, UFLC 

Corresponding author email:
Researcher id: D-8663-2014

Article citation

Shanmugam R*, Kirthi A, Madhuri K, Ashok Kumar C K, LalithaPriyanka Development and validation of a RP- UFLC method for estimation of synthetic steroid hormone danazol. Hygeia.J.D.Med2016; 8(1):27-34.  Available from http://www.hygeiajournal.com / Article ID-Hygeia.J.D.Med/154/16.


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