Chemometric Assisted Method Development for Teneligliptin and Metformin by Stability Indicating RP-HPLC Technique and its Validation

Abstract

Quality of pharmaceutical products was considered as an important aspect by all regulatory bodies. The quality by design for the method development of the pharmaceuticals gives us more robust method. J.M. Juran, a well known quality expert developed the concept quality by design. Here, the appellant will plan the design space which had been undergoing regulatory analysis and consent [1-5]. International conference on harmonization in its Q8 pharmaceutical development, Q9 quality risk assessment and Q10 pharmaceutical quality system gives compelling conditions regarding quality of products. QbD basically aids to execute Q8 and Q9. Food and drug administration perspective of QbD is a systematic approach to product and process design and development [6-9]. QbD does not necessarily mean less analytical testing alternately, it means the right analysis at right time, and is based on science and risk assessment.