ISSN : 2663-2187

A Stability Indicating Liquid Chromatographic Assay Method for the Simultaneous Determination of anti-cancer drugs in bulk and Pharmaceutical Dosage Forms

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Pavan Kumar.V*, S. Jagadeesh, S. Mahirah , V.Amaravathi
» doi: 10.48047/AFJBS.6.13.2024. 2780-2791

Abstract

Combination Dosage Forms generally refers to pharmaceutical formulations which contains two or more active ingredients in a single dosage unit or formulation. These combination dosage forms serve several important purposes in health care and play a crucial role by improving treatment outcomes, enhancing patient adherence and optimizing therapeutic regimens for various medical conditions. In this present strategy a stability indicating assay method was developed and validated as per ICH Guidelines for the simultaneous quantitation of Letrozole and Ribociclib in commercially available pharmaceutical dosage forms. The proposed method is based on Isocratic elution using Octa Decyl Silane (ODS) C18 (250*4.6 mm, 5 µm) column with a flow rate of 0.9 ml/min. The linear ranges for Letrozole and Ribociclib were found to be in the range of 1.25 -6.25µg/ml and 100-500 µg/ml. During the process of validation the intra and Interday Precision % RSD value was found to be less than 2 and recovery was in the range of 98- 102%. The method was successfully applied for routine quality control analysis of dosage forms

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