BIOANALYTICAL METHOD FOR TERIFLUNOMIDE ESTIMATION BY HPLC

POOJA GURAV; MRINALINI DAMLE

doi:10.22159/ajpcr.2023.v16i1.45652

Authors

POOJA GURAV Department of Quality Assurance, All India Shri Shivaji Memorial Society’s College of Pharmacy, Kennedy Road, Near RTO, Pune, Maharashtra, India. https://orcid.org/0000-0001-5267-6262
MRINALINI DAMLE Department of Quality Assurance, All India Shri Shivaji Memorial Society’s College of Pharmacy, Kennedy Road, Near RTO, Pune, Maharashtra, India.

DOI:

https://doi.org/10.22159/ajpcr.2023.v16i1.45652

Keywords:

HPLC, Teriflunomide, Paliperidone palmitate, Bio-analytical, Validation

Abstract

Objective: The aim of this study was to develop and validate simple and economical HPLC method for estimation of Teriflunomide in human plasma.

Methods: HPLC method was developed using AgilentEclipse XBD C8 (4.6 mm×150 mm) as stationary phase and mobile phase used was ammonium acetate buffer: methanol (40: 60 v/v). The detection was carried at wavelength 294 nm. A simple protein precipitation technique was used with acetonitrile as protein precipitating agent and Paliperidone palmitate was chosen as internal standard. Validation was carried out as per USFDA guidelines for bio-analytical method.

Results: The linearity range set was 10–60 μg/ml. The value of regression coefficient was found to be 0.9953. Retention time for Teriflunomide was found to be 4.8 min. The developed method was validated for various parameters such as specificity, linearity, accuracy, precision, recovery, and stability.

Conclusion: The developed method is simple, rapid, and economical for estimation of Teriflunomide in human plasma.

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Author Biography

MRINALINI DAMLE, Department of Quality Assurance, All India Shri Shivaji Memorial Society’s College of Pharmacy, Kennedy Road, Near RTO, Pune, Maharashtra, India.

Professor,

Quality Assurance Department

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