Development and Validation of Stability Indicating RP-HPLC Method for Quetiapine in Bulk and Tablet Formulation

Author(s)

Patel, K.K., Pandya, S.S., Patel, V.S.

Author's Affiliation

Abstract

A simple, precise, rapid and accurate stability indicating RP HPLC method was developed for the assay of Quetiapine in tablet formulation. The solvent system and wavelength were optimized to maximize the sensitivity of the proposed method. The separation was carried out on a hypersil BDS C18 (25cm*0.46cm) 5 μ particle size with mobile phase Acetonitrile, Water (85: 15%v/v) at a flow rate of 1.0 ml/min. The detection is carried out at 226.4nm. The retention time of the drug was 4.48 min.  The Linearity was observed in the concentration range of 10 -30 µg/ml with correlation coefficient 0.9956. The method was validated for accuracy, precision, linearity, LOD & LOQ of the sample solution. Quetiapine stock solutions were subjected to acid, base, oxidation, Photo and thermal degradation. The degraded peaks were well resolved from the pure drug peak with a significant difference in their retention time values.

Keywords

Stability indicating, RP-HPLC, Quetiapine, validation, tablet formulation

Cite This Article

Patel, K. K., Pandya, S. S., Patel, V. S. (2017). Development and Validation of Stability Indicating RP-HPLC Method for Quetiapine in Bulk and Tablet Formulation. International Journal for Pharmaceutical Research Scholars (IJPRS), 6(2), 209 - 215.