Abstract
APPLICATION OF QUALITY BY DESIGN APPROACH FOR DEVELOPMENT AND VALIDATION OF ANALYTICAL RP-HPLC METHOD FOR LURASIDONE IN BULK AND TABLET DOSAGE FORM

Dr. Deelip Derle, Vrushali Shelke*, Ekta Patil, Sayyed Shoeb and Adhiraj Derle

ABSTRACT

The current research is aimed to study and investigate the estimation of Lurasidone in the bulk drug and its tablet dosage by a developed and validated RP-HPLC method. The method was developed using Quality by Design principles. All the computations for the current optimization study and statistical analysis were performed using Design Expert® software. The 33 randomized response surface designs with a Box-Behnken design were used with 17 trial runs to study the impact of three factors on the three key response variables. The Flow rate, pH of mobile phase and Mobile phase composition were selected as independent variables. The retention time, theoretical plate number and tailing factor were selected as dependent variables based on risk analysis. The resulting data was processed into Design Expert 11 software and analysed statistically using analysis of variance (ANOVA).The analysis were carried out using HPLC of Waters, series 2482 (Binary pump, Orochem C18 column, Waters 2489 -UV-Visible Detector, Breeze 2 software) with manually injecting 10 μl of mobile phase consisting of Methanol : Water (85:15), maintaining isocratic flow. The calibration was linear in the range of 200-300μg/ml. The RSD for accuracy, precision and robustness was observed within the range (less than 2%). System suitability parameters were within the limit. The validated limit of quantitation (LOQ) and limit of detection (LOD) was 24.80μg/ml and 8.18μg/ml respectively. The assay result of marketed formulation for Lurasidone was 98.76 %. Hence accurate, precise, and robust method were developed and validated.

Keywords: HPLC, Lurasidone, Quality by Design, Validation, Design Expert.


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