Abstract

FORCED DEGRADATION STUDIES ON LINAGLIPTIN TABLETS BY REVERSE PHASE HPLC METHOD

Dr. Praveen Kumar Ashok, Ms. Arati Tamta, Dr. Divyanshi Rastogi and Binod Acharya*

Abstract

The purpose of this research is to perform forced degradation studies of Linagliptin Tablets. A force degradation study of Linagliptin tablets 5 mg was carried out simultaneously. Force degradation is the degradation of new drug substances and drug products at condition sever than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structures of the degradation products. A simple and accurate method was developed for the study of the degradation pathway. The drugs substances were subjected to different degradation conditions i.e. Acid degradation, Base degradation, Oxidative degradation, photolytic degradation and Thermal degradation for different time interval. For Acid, Base and Oxidative degradation the drug substance were treated for 1st hour, 10th hour and 24 hour. For the Thermal and Oxidative degradation condition the drugs substance were treated for Day-1, Day-3 and Day-5. Force degradation studies was performed as per ICH Guidelines, Q1A (R2), Stability testing of New Drugs Substances and products. By Conducting the degradation study the Percentage degradation was calculated by performing assay (amount of the drug) in each condition. A simple, accurate, precise, validated and sensitive analytical RP-HPLC method was selected for analysis of drug Substances. The tablets samples were stable in the degradation study. No sample degraded more than 20%. Hence from this study it can be concluded that dosage form of Linagliptin are physically and chemically stable for their shelf life.

Keywords: Forced Degradation Studies, ICH Guidelines, Linagliptin, Stress conditions.