METHOD DEVELOPMENT AND VALIDATION OF QUETIAPINE FUMARATE BY RP - HPLC METHOD

About Author:
Sharath Kumar Pallikonda*1, Srikanth Subburu2, Shanker Reddy Soma2, Chandra Shekar Reddy3
1,2Vathsalya College Of Pharmacy,
Bhongir, Dist: Andhra Pradesh, India - 508 116

Abstract
A simple, sensitive, rapid, robust and reproducible method for the determination of Quetiapine fumarate in bulk and pharmaceutical formulation (Tablets) was developed using reverse phase high performance liquid chromatographic method (RP-HPLC). The RP-HPLC analysis was performed isocratically on XTERRA C18 (4.6X150mm), analytical column using a mobile phase consisting of ortho phosphorus buffer and acetonitirle in the Ratio of 60:40v/v, with a flow rate of 0.6ml/min. The analyte was monitored with UV detector at 290nm. The developed method Quetiapine fumarate elutes at a run time of 10 min. The proposed method is having linearity in the concentration range from 40 to 80 μg/mL of Quetiapine fumarate. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), ruggedness, and robustness. The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.

REFERENCE ID: PHARMATUTOR-ART-1141

Introduction
Quetiapine Fumarate is chemically 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl) ethoxy] ethanol hemifumarate. It is anatypical antipsychotic approved for the treatment of schizophrenia, acute episodes of bipolar disorder (manic, mixed or depressive), and as n augmentor for the maintenance treatment of depression and bipolar disorder.The literature survey (AshishBaldi et al., 2010) reveals that there is some HPLC methods have been reported. The aim of the present study was to develop and validate a simple, isocratic RP-HPLC (Remington, 2007; Skoog,  2004; Chatwal GR, 2004) method for the determination of Quetiapine fumarate in tablets. The developed method was validated using ICH guidelines for validation (ICH, 1995). Today, RP-HPLC is the most popular analytical technique for separating complex mixtures in the chemical, pharmaceutical and biotechnological industry. RP-HPLC is the opposite of normal-phase chromatography, with a nonpolar stationary phase and a polar, largely aqueous mobile phase. The most common stationary phases used are octadecyldimethyl (C18) phases with silica as the solid support. Silica has a small pH range (3 to 8) where mixtures can be separated without degradation of the column performance. Above pH 8, silica supports dissolve and destroy the column. Below Ph 3, the silicon-carbon bond is cleaved, and the column is destroyed. The separation is achieved by analytes having different interactions with the stationary phase. In RP-HPLC, solutes are separated using their hydrophobicity. A more hydrophobic solute will be retained on the column longer than a less hydrophobic one. Also, polar solutes will interact with the silica surface to cause peak tailing. The mobile phase is one of the two components involved in the separation process. Water is generally one of the components of a binary mixture in RP-HPLC. Water is considered to be the weak component of the mobile phase and does not interact with the hydrophobic stationary phase chains. The RP-HPLC method reported in this study was validated in accordance with the International Conference on Harmonization (ICH) guideline (ICH, 1997) and best practice (Shabir GA et al., 2007; Shabir GA et al., 2003; USFDA, 2000). Specificity, linearity, precision (repeatability and intermediate precision), accuracy, robustness, limit of detection and limit of quantitation were evaluated.

OBJECTIVE
Literature reveals different methods for their analysis in their formulations. But our present objective is to develop a new, simple, precise & accurate method for its analysis in formulation after a detailed study a new RP-HPLC method was decided to be developed and validated. Applying developed method to marketed formulation.

METERIALS, INSTRUMENTS AND METHODS

Chromatographic conditions

Column

C18 XTERRA (4.6 X 150 mm).

Column temperature

Room temperature 24±20C

Flow rate

0.6ml/min.

Injection volume

20 μl.

Wavelength

290 nm

Run time

10 min

Diluent

mobile phase

Mobile phase composition

buffer and acetonitrile 60:40 composition

Pump

Water Alliance

Injector

Rheodyne

Reagents

Instruments

Tablet brand

Water HPLC grade

WATERS (ISOCRATIC SYSTEM)

Quetiapin (sun pharma)

Quetiapine working standard

Pump: Waters Alliance 2695

Detector:UV-Visible model 2487

 Injector:  Auto Sample

Column:  C18  XTERRA (4.6 x 150 mm )

  LABEL CLAIM: Each film-   coated tablet contains Quetiapine: 25 mg


Methanol working standard

.    Elicho PH - Meter 


Ortho phosphoric buffer

Afcoset Digital Balance


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