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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF LURASIDONE HCl IN BULK AND PHARMACEUTICAL DOSAGE FORM

A. Sravani Kasyap* and K. Vijayasri

ABSTRACT

RP-HPLC was developed and validated for the estimation of Lurasidone HCl as per ICH guidelines.. A simple, fast, accurate and precise RP-HPLC method was developed by using methanol: water in the ratio of 70:30 using 0.01% Ortho Phosphoric acid in method 1 and Acetonitrile:Water in the ratio 50:50 using 0.01% Ortho phosphoric acid in method 2. The method was developed in Eclipse C18 column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 2.5- 15μg/ml with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 99.2 to 102.4% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were found for RPHPLC method. The % RSD is <2% which indicates the accuracy and precision of the method. The above method was a rapid tool for routine analysis of Lurasidone in the bulk and in the pharmaceutical dosage form.

Keywords: RP-HPLC, Methnol: water, Acetonitrile: water, lurasidone, validation, ortho phosphoric acid.


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