Abstract

DEVELOPMENT AND VALIDATION OF UV-VIS SPECTROPHOTOMETRIC METHOD FOR QUANTIFICATION OF EVEROLIMUS IN TABLET

M. S. Kalshetti* and S. G. Gumate

ABSTRACT

Everolimus is derivative of rapamycin and used as immunosuppressant to prevent rejection of organ transplantation. The present study describes development of simple, rapid, and validated UV-VIS spectrophotometric method for quantification of everolimus in tablet dosage form. The analytical method was developed using methanol as solvent. The developed method is validated as per ICH guidelines. The UV spectrum of Everolimus in methanol showed maximum absorption at 275 nm. The method showed good linearity (R2 = 0.9999) in the range of 5 to 25 μg/mL. The method is precise (%RSD 0.573) and good recovery (98%). This method is useful for quantification of everolimus in dosage forms.

Keywords: Everolimus, UV visible spectrophotometer, Methanol, Method development and validation.