Document Type : Original Article
Authors
1
Biju Pattanayak University of Technology, Rourkela-769004, Odisha, India
2
Dr. B. C. Roy College of Pharmacy and AHS, Durgapur-713206, West Bengal, India
3
Department of Pharmaceutical Technology, JIS University, 81, Nilgunj road, Kolkata- 700109, India
4
Roland Institute of Pharmaceutical Sciences (Under Biju Pattanayak University of Technology, Rourkela-769004), Odisha, India
Abstract
In this present project, a novel, Reverse Phase - High Performance Liquid Chromatographic analytical method was developed for determination of Fulvestrant Injection, which is fast & economical too. Retention time of Fulvestrant was at 21 minutes, which quite fast by using the Zorbax XDB C18; 150 × 4.6 mm, 3.5, column as stationary phase with mobile phase consisted of a mixture of Mobile phase –A: Water, Acetonitrile and Methanol (410:320:270), Mobile phase-B: Acetonitrile, Methanol and Water (490:410:100) in a gradient elution and at a flow rate of 2 ml/min. Detection was carried out at 225 nm in HPLC. Newly developed method shows linearity in the range of 80-120 μg/ml & correlation co-efficient for this method was found to be 0.999. The accuracy studies showed % recovery of Fulvestrant injection, was in the range 99.7-102 % in the newly developed method. Validation parameters were within the permitted limits so this method was found to be precise, accurate and specific. Present method is better in terms of economical aspect, easy to perform & is very much specific towards the targeted drug, which is evidenced from the validation parameter. So this unique method can be efficiently employed for determination of Fulvestrant in commercial products, economically.
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