NOVEL REVERSE PHASE HPLC METHOD DEVELOPMENT AND VALIDATION OF QUETIAPINE FUMERATE IN BULK AND TABLET DOSAGE FORM

Sudarshan Reddy P; Panjagala Satyanarayana; Karthik Varma K; Naga Raju; Siva Kumar G; Shanmugasundaram P

Authors

Sudarshan Reddy P
editorijipsr@gmail.com
School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.
Panjagala Satyanarayana School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.
Karthik Varma K School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.
Naga Raju School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.
Siva Kumar G School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.
Shanmugasundaram P School of Pharmaceutical Sciences, Vels University, Zameen Pallavaram, Chennai, India – 600 117.

Keywords:

HPLC, Validation and quantification, Quetiapine fumerate, tablet.

Abstract

A precise and feasible high-performance liquid chromatographic (HPLC) method for the analysis of the novel antipsychotic drug quetiapine in tablet dosage form has been developed. The analysis was carried out on a Phenomix Stainless Steel C18 (250 x 4.6 mm, 5 μ) reversed-phase column, using a mixture of phosphate buffer (pH 3), acetonitrile, methanol (50:40:10) as the mobile phase using a low pressure gradient mode with flow rate at 0.8ml/min. The injection volume was 20µl..The retention time of the drug was 4.69 min. The method produced linear responses in the concentration range of 1 to 5μg/ml of Quetiapine fumerate. The LOD and LOQ values for HPLC method were found to be 0.0167 and 0.0506 μg/ml respectively. The method was found to be applicable for determination of the drug in tablets.

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