Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAROGLITAZAR MAGNESIUM IN PHARMACEUTICAL DOSAGE FORM BY QUALITY BY DESIGN APPROACH

Astha P. Sanyal*, Khushbu K. Patel, Ushma B. Patel and Dr. Chhaganbhai N. Patel

ABSTRACT

Quality by Design is a systemic approach to development that begins with the predefined objective and emphasizes product and process understanding and process control, based on sound science and quality risk management. The objective of this present study was to develop and demonstrate an integrated multivariate QbD approach to develop and quantify the constitute concentration of Saroglitazar magnesium API and tablet dosage form. To facilitate studies investigating the determination of Saroglitazar magnesium, RP-HPLC method was developed and validated according to ICH Q2 guidelines. The developed method employed mobile phase Methanol and Water (90: 10 v/v) and flow rate 0.8 mL/min which was optimized with the help of Design Expert Software. Method was developed using column C18 Waters (150 × 4.6 mm, 5μm) and detection wavelength is 295nm. The retention time was 1.993 min. High linearity of developed method was confirmed over concentration range of 20- 100 μg/mL and co-relation co-efficient is 0.9971. The percentage RSD for precision and accuracy of the method was found to be less than 2%.

Keywords: Saroglitazar magnesium (SAR), Quality by Design (QbD), Design Expert optimization, RP-HPLC, Validation.