A Novel RP – HPLC Analytical Method Development and Validation of Fulvestrant Injection as per ICH Guidelines | ||||
| Egyptian Journal of Chemistry | ||||
| Article 35, Volume 64, Issue 4, April 2021, Page 2047-2055 PDF (571.54 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/ejchem.2021.56503.3215 | ||||
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| Authors | ||||
Somsubhra Ghosh1; Sudip Mandal   2; Tathagata Roy3; B. V. V. Ravikumar4
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| 1Biju Pattanayak University of Technology, Rourkela-769004, Odisha, India | ||||
| 2Dr. B. C. Roy College of Pharmacy and AHS, Durgapur-713206, West Bengal, India | ||||
| 3Department of Pharmaceutical Technology, JIS University, 81, Nilgunj road, Kolkata- 700109, India | ||||
| 4Roland 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. | ||||
| Keywords | ||||
| RP HPLC; Fulvestrant injection; Validation; ICH guidelines; Method Validation | ||||
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