Stability indicating high performance liquid chromatographic (HPLC-DAD)‎ determination of trandolapril in bulk drug and formulation

Dissertant

al-Hawwash, Lina A.

Thesis advisor

Salim, Mahir L.
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

2012

English Abstract

The purpose of this study was to develop a new stability indicating method for the analysis of trandolapril in formulation and raw material.

In the present study a rapid, simple, economical reverse phase HPLC-DAD procedure has been developed for the determination of trandolapril.

The trandolapril was separated isocratic ally on Hypersil-Gold C18 column (Length-250 mm, Diameter- 4.6 mm, Particle size- 5 urn) with a mobile phase consisting of 50 % acetonitrile, 50 % water (containing 0.25 ml / L triethylamine, final pH was adjusted to 3.0 ± 0.1), operated at 25 ± 1 °C with a retention time less than 6 min.

The total run time of the stressed study was 20 mins.

The eluted drug was identified and monitored on a Photo Diode- Array detector (PDA) at 210 nm.

The linearity of the method was excellent (r > 0.9999) over the concentration range of I-24 ug / ml : the LOD and LOQ were 0.0566 ug / ml and 0.1715 ug / ml respectively.

The statistical evaluation of the method was examined by performing intraday and interday precision analysis.

The overall precision (CV.

RSD) was less than 2 %.

Mean recovery of trandolapril was more than 99 %, no interference was found from the other ingredient or component present in the preparation.

The result of stability studies indicates that the drug was stable when exposed to direct sunlight or UV light.

The drug gives 6 different oxidative products on exposure to hydrogen peroxide (oxidative stress).

Under alkaline condition it was converted to trandolaprilate and other derivative products.

Slight degradation (less than 0.4 %) was observed in acidic conditionIn conclusion the method presented here is sensitive, rapid, accurate, precise, economic, robust, rugged and selective for the routine analysis of the drug in formulation and raw material.

Main Subjects

Pharmacy, Health & Medical Sciences

Topics

• Fraud
• Drugs

• APA
• MLA
• AMA

Language

English

Data Type

Arab Theses

Record ID

BIM-311671