Development and Validation of a Stability Indicating RP-UPLC Method for Determination of Quetiapine in Pharmaceutical Dosage Form

Rakshit Kanubhai Trivedi

doi:10.3797/scipharm.1009-12

Abstract

The present work reports a stability indicating reversed phase ultra performance liquid chromatography (RP-UPLC) method for the quantitative determination of quetiapine in pharmaceutical dosage form. The chromatographic separation is performed on an Agilent Eclipse Plus C18, RRHD 1.8 μm (50 mm x 2.1 mm) column using gradient elution. The optimized mobile phase consists of 0.1 % aqueous triethylamine (pH 7.2) as a solvent-A and 80:20 v/v mixture of acetonitrile and methanol as solvent-B. The eluted compounds are monitored at 252 nm wavelength using a UV detector. The developed method separates quetiapine from its five impurities/degradation products within a run time of 5 min. Stability indicating capability of the developed method is established by analyzing forced degradation samples in which the spectral purity of quetiapine is ascertained along with the separation of degradation products from analyte peak. The developed RP-UPLC method is validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity, robustness and filter compatibility.

Highlights

Quetiapine, {2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy}ethanol, is an atypical antipsychotic drug with a unique receptor-binding profile belonging to a new chemical class, the dibenzothiazepine derivatives [1,2,3,4]
UPLC is a new category of separation technique based upon well-established principles of liquid chromatography, which utilizes sub-2 μm particles for stationary phase
The spiked solution of related compounds (N-Oxide, S-Oxide, Que-IV, Des-E, Dimer) and QUE were subjected to separation by reversed phase ultra performance liquid chromatography (RP-UPLC)

Summary

Introduction

Quetiapine, {2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy}ethanol, is an atypical antipsychotic drug with a unique receptor-binding profile belonging to a new chemical class, the dibenzothiazepine derivatives [1,2,3,4]. This technology has been applied to the method development and validation study of assay determination of quetiapine dosage forms. We focused on developing a selective, fast, cost-effective and stability-indicating method using this advance technique (UPLC) for the assay determination of quetiapine in solid pharmaceutical dosage forms.

Results

Conclusion