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136871

A Novel RP – HPLC Analytical Method Development and Validation of Fulvestrant Injection as per ICH Guidelines

Article

Last updated: 01 Jan 2025

Subjects

-

Tags

Pharmaceutical Chemistry

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.

DOI

10.21608/ejchem.2021.56503.3215

Keywords

RP HPLC, Fulvestrant injection, validation, ICH guidelines, method validation

Authors

First Name

Somsubhra

Last Name

Ghosh

MiddleName

-

Affiliation

Biju Pattanayak University of Technology, Rourkela-769004, Odisha, India

Email

somsubhaghosh@gmail.com

City

Kolkata

Orcid

-

First Name

Sudip

Last Name

Mandal

MiddleName

-

Affiliation

Dr. B. C. Roy College of Pharmacy and AHS, Durgapur-713206, West Bengal, India

Email

gotosudip79@gmail.com

City

Durgapur

Orcid

orcid.org/0000-0003-

First Name

Tathagata

Last Name

Roy

MiddleName

-

Affiliation

Department of Pharmaceutical Technology, JIS University, 81, Nilgunj road, Kolkata- 700109, India

Email

troy@isuniversity.ac.in

City

-

Orcid

-

First Name

B. V. V.

Last Name

Ravikumar

MiddleName

-

Affiliation

Roland Institute of Pharmaceutical Sciences (Under Biju Pattanayak University of Technology, Rourkela-769004), Odisha, India

Email

ravikuar_bvv@yahoo.co.uk

City

-

Orcid

-

Volume

64

Article Issue

4

Related Issue

22914

Issue Date

2021-04-01

Receive Date

2021-01-04

Publish Date

2021-04-01

Page Start

2,047

Page End

2,055

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_136871.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=136871

Order

35

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

https://ejchem.journals.ekb.eg/

MainTitle

A Novel RP – HPLC Analytical Method Development and Validation of Fulvestrant Injection as per ICH Guidelines

Details

Type

Article

Created At

22 Jan 2023