Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF LETERMOVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Mohammed Tajuddin, Rakesh Kumar Jat and Nagakanyaka Devi Paladugu*

Abstract

The proposed work was accurate and precise stability indicating RPHPLC method has been developed and validation of Letermovir, in tablet dosage form. The separation was achieved on a Kromasil C18 (4.6×250mm, 5μ) column using a mixture of Methanol: water (60: 40% v/v) as the mobile phase at a flow rate of 1.0 mL/min and detected 247 nm. The retention time of Letermovir 3.2 minutes. The linear responses in the concentration range of 10-60 μg/mL of Letermovir. The method precision for the determination of assay was less than 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Letermovir; RP-HPLC; Validation; Tablet dosage forms; PDA Detection; ICH Validation.