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

مقدم أطروحة جامعية

Baradan, Majid Y.

مشرف أطروحة جامعية

Shakya, Ashok Kumar

الجامعة

جامعة عمان الأهلية

الكلية

كلية الصيدلة و العلوم الطبية

القسم الأكاديمي

قسم العلوم الصيدلانية

دولة الجامعة

الأردن

الدرجة العلمية

ماجستير

تاريخ الدرجة العلمية

2014

الملخص الإنجليزي

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.

التخصصات الرئيسية

علم الصيدلة

الموضوعات

• الأدوية

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-412353