Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE MONOHYDRATE

Ankita*, Amardeep Ankalgi, Kamya Goyal and C. P. S. Verma

ABSTRACT

Diabetes mellitus is a group of metabolic disorders characterized by a high blood sugar level over a prolonged period of time. sitagliptin phosphate monohydrate is an anti-diabetic medication used to treat type 2 diabetes. It must be given in single or in mixture with distinctive Antidiabetic drugs such as Metformin, glibenclamide, Vildagliptin as well as antihypertensive drugs such as Simvastatin also used in drugs used in diabetic Naphropathy. The UV- visible spectrophotometer is a frequently used method for quantitation of drugs. This method has been universally applicable in the determination of individual components in a mixture of fixed dose combinations.We aim to develop a spectroscopic method for estimation of sitagliptin phosphate monohydrate by using UV spectrophotometry. The method was validated as per ICH guidelines for the parameters: Linearity, Accuracy, precision, Robustness and specificity. The recovery studies assure the accuracy and precision of the method. This method can be successfully applied for the Control analysis of the drug and also for routine analysis.

Keywords: UV spectrophotometry, sitagliptin phosphate monohydrate, Diabetes mellitus Validation.