Abstract

“ANALYTICAL QUALITY BY DESIGN APPROACH FOR HPLC METHOD DEVELOPMENT AND VALIDATION OF TOFACITINIB CITRATE IN PHARMACEUTICAL FORMULATIONS”

Geetesh Sharma*, Dr. Zarna Dedania

ABSTRACT

Achieving a certain predictable quality with intended and predefined parameters is known as quality by design (QbD). Understanding dependent variables, different factors, and their interaction effects by a desired set of experiments on the answers to be analysed is a crucial part of the QbD. The development and validation of a risk-based HPLC technique for Tofacinitinib Citrate in pharmaceutical dosage form. An effective experimental strategy based on the central composite design of the mobile phase and Flow rate, two essential elements of the RP-HPLC process, is described. The Design Expert software 13.0 edition was used to optimise the chromatographic settings, which included using the Phenomenex ODS column C18 (250mm 4.6mm, 5.0), Methanol: Water (77:23 v/v) mobile phase composition, a flow rate of 0.8 ml/min, and a retention period of 4.273 min. At a detection wavelength of 287 nm, the devised technique was shown to be linear with r2 = 0.999 over a range of 2-10µg/ml. The tailing factor and theoretical plates—the system suitability test parameters—were discovered to be 1.694 and 23978.12, respectively. The% RSD for intraday and interday precision was discovered to be 0.95-1.03 and 0.92-1.22, respectively. The robustness percentages were under 2%. The assay yielded a result of 99.88 ± 0.45%. Conclusion: The central composite design experimental design describes the interrelationships of mobile phase and Flow rate at three different level and responses to be observed were retention time, theoretical plates, and peak asymmetry with the help of the Design Expert 13.0 version.

Keywords: Analytical Quality by Design, HPLC, Tofacitinib Citrate, Design approach.