Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN AND TENEGLIPTININ IN TABLET DOSAGE FORM BY RP-HPLC

*Jitesh V. Bhoyar, Dr. Anil P. Dewani and Dr. A. V. Chandewar

ABSTRACT

Analytical chemistry may be defined as the science and art of determining the composition of materials in terms of the elements of composition contained. Pharmaceutical analysis is a bench of science that deals with the analytical procedures used to determine the purity, safety and quality of drugs and chemicals. It contains procedures to determine the identity, strength, quality and purity of new compounds. It also involves procedures for separating, identifying, and determining the relative amount of the components in sample of matter. Quality assurance plays a key role in finding the safety and efficiency of medicines. It has highly specific and sensitive analytical methods for the design, development, standardization and quality control of medicinal products. They are equally important for the pharmacokinetics and drug metabolism studies, both which are important for the assessment of bioavailability and clinical response.

Keywords: Reverse phase high pressure liquid chromatography (RP-HPLC); Terbinafine Hydrochloride; International Conference on Harmonisation (ICH); Photodiode array (PDA) detection.