Abstract

A REVIEW ON FORCED DEGRADATION STUDIES ON LINAGLIPTIN TABLET BY REVERSE PHASE HPLC METHOD

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

ABSTRACT

The objective of this forced degradation study of drug product and drug substance is to generate documented evidence that the stability and excipient is compatible with Linagliptin tablets. Forced degradation study can provide information for stability study and propose shelf life of the product depending on percentage deviation of the obtained result. Review should demonstrate that the drug product stays of quality standard and meets all required specification throughout its shelf life. The purpose of forced degradation study of Linagliptin Tablets is to establish scientific documented evidence which provide high degree of assurance that the excipient and method of analysis is capable of producing safe and effective product that meets the established specifications.

Keywords: Forced degradation, Linagliptin Tablets.