Abstract

VALIDATED STABILITY-INDICATING HPTLC METHOD FOR ESTIMATION OF TAFAMIIDIS IN SOFT GEL CAPSULE DOSAGE FORM

Sayali Patil*, Bhushan Sonawane, Vijay Kumar Munipalli, S. S. Parikh, Raman Mohan Singh and Smita Nayak

ABSTRACT

A novel and accurate high performance thin-layer chromatography (HPTLC) method was developed and validated for determination of Tafamidis (TAF) in their soft gel capsule dosage form. Separation of active ingredients from its dosage form was done on pre-coated HPTLC plate (silica gel 60 F254), using toluene: ethanol: glacial acetic acid in the ratio of 90: 10: 0.02 v/v/v as mobile phase. The system was found to give dense band and acceptable Rf 0.32. The developed method for TAF was scanned at the wavelength for 310 nm. Additionally, TAF was subjected to acid-alkali hydrolysis, thermal, oxidation, and photo degradation and the well resolved peaks found for pure drug and degraded products with different Rf. The present method was validate as per ICH guidelines. The molecule was found to be linear between range 20-100 μg/ml with correlation coefficient of 0.9993. The limit of quantitation and limit of detection was found to be 7.57 μg/ml and 2.21 μg/ml. Obtained results for accuracy and precision studies indicates that the method can be used for routine analysis of TAF in pharmaceutical formulation.

Keywords: TAF, high-performance thin layer chromatography, quantification, validation, forced degradation studies.