Development, optimization and validation of HPLC method for determination of febuxostat using design of experiments (DoE)‎

Dissertant

Baradan, Majid Y.

Thesis advisor

Shakya, Ashok Kumar

University

Al-Ahliyya Amman University

Faculty

Faculty of Pharmacy and Medical Sciences

Department

Pharmaceutical Sciences

University Country

Jordan

Degree

Master

Degree Date

2014

English Abstract

The purpose of this study was to develop a new high performance liquid chromatographic for determination of febuxostat in tablet dosage form.

In the present study a rapid, simple, economical HPLC-PDA procedure has been developed and validated.

The HPLC method was developed and optimised using Box-Behnken-design (BBD), after studying the physicochemical properties of febuxostat (solubility, melting point, 1R, UV).

The Optimized mobile phase was [34% buffer (250|il TEA/L), 33% acelonitrile and 33% methanol , the pi I value was adjusted to 3.0 10.10] using orthophosphoric acid.

The flow rate was 1.0 ml/min, the signals were monitored using PDA detector (set between A 200-400 nm)using windows based LC solution software quantitation was carried out at wave length of 315 nm.

The linearity range of the method was from 5 to 50 p.g/ml for febuxostat.

LOD was 0.3201 pg/ml for febuxostat, whereas LOQ was 0.9702|ig/ml.

The precision of the method was less than 2% which indicates highly precise result during the study.

I he accuracy of the method were ranged from 99.39%-l 00.97%.

There were two minor degradation products of febuxostat after exposure to hydrogen peroxide (35%) with retention time 2.34 and 2.66 while exposure to alkaline stress resulted 5 different minor degraded products.

No degradation products of febuxostat were observed after exposure to UV light.

In conclusion the method presented here is sensitive, rapid, accurate, precise, economic, robust, rugged and selective for the routine analysis of the drug in formulation (tablet) and raw material.

Main Subjects

Pharmacology

Topics

American Psychological Association (APA)

Baradan, Majid Y.. (2014). Development, optimization and validation of HPLC method for determination of febuxostat using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University, Jordan
https://search.emarefa.net/detail/BIM-412353

Modern Language Association (MLA)

Baradan, Majid Y.. Development, optimization and validation of HPLC method for determination of febuxostat using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University. (2014).
https://search.emarefa.net/detail/BIM-412353

American Medical Association (AMA)

Baradan, Majid Y.. (2014). Development, optimization and validation of HPLC method for determination of febuxostat using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University, Jordan
https://search.emarefa.net/detail/BIM-412353

Language

English

Data Type

Arab Theses

Record ID

BIM-412353