Abstract
This paper describes the development and validation of an isocratic LC-UV method for the assay of sitagliptin phosphate in tablets, a drug recently approved for the treatment of type 2 diabetes mellitus (DM). The method employs a Phenomenex® C18 column (150mm x 4.6mm I.D., 5μm) with 0.025 M phosphate buffer pH 6.8: acetonitrile (60:40, v/v) as mobile phase, at a 0.8 mL min-1 flow rate and UV detection at 267 nm. The chromatographic separation was obtained within a retention time of 3.7 min. The method was linear (r = 0.9999) in the range of 25-75 μg.mL-1. The method’s specificity and stability-indicating capability were proved through force degradation studies, being the peak purity evaluated by PDA detector. Sitagliptin phosphate was exposed to oxidative, hydrolytic and photolytic stress conditions, and no interference from degradation products was observed. The method has shown good and consistent recoveries (mean value 100.0%) with low intra and inter-day relative standard deviation (RSD). In robustness study, it was observed that peak area was unaffected by small changes in critical factors. The validated method can be successfully applied to determine sitagliptin in tablets and in stability studies.
Keywords: Liquid chromatography, method validation, sitagliptin phosphate, sitagliptin assay, stability-indicating, sitagliptin tablets, type 2 diabetes mellitus
Call for Papers in Thematic Issues
Advancements in biomedicine, corrosion inhibition/monitoring, and lubrication of carbon dots
Carbon dots, a class of carbon-based nanomaterials, have garnered substantial interest in various scientific and engineering fields due to their unique properties, including excellent optical properties, outstanding biocompatibility, easy preparation, good dispersity, ultrasmall size, low toxicity and environmental friendliness. This special issue of Current Analytical Chemistry aims to showcase cutting-edge ...read more
Analytical methods for environmental and food analysis
In recent years, the study of the chemical composition of food and the environment depends on analytical methods in order to acquire information about the chemical composition, processing, quality control and contamination of soil, water, air, plants and foods, aspects very important for food safety and environmental quality control. There ...read more
Applications of artificial intelligence in chemical analysis
Artificial intelligence (AI) has demonstrated its versatility in almost all scientific fields, especially analytical chemistry, which is leading the way in the integration of AI. According to Chemical Abstract Services, one of the major disciplines contributing to AI-related publications and patents is analytical chemistry. That?s because techniques such as deep ...read more
Bioanalytical and Biosensor Technologies for Target Molecules
Bioanalytical and biosensor technologies constitute the core of detecting and sensing diverse molecules within living organisms, encompassing proteins, DNA, small molecular metabolites, and beyond. These molecules assume pivotal roles in biological processes, rendering their analysis and sensing indispensable for comprehending biological phenomena and unraveling disease mechanisms. In the current landscape ...read more
Related Journals
Anti-Cancer Agents in Medicinal Chemistry
Current Computer-Aided Drug Design
Current Bioactive Compounds
Combinatorial Chemistry & High Throughput Screening
Current Medicinal Chemistry
The Natural Products Journal
Current Catalysis
Current Chinese Chemistry
Current Chinese Science
Current Topics in Chemistry
Related Books
Botanicals and Natural Bioactives: Prevention and Treatment of Diseases
Biosurfactants: A Boon to Healthcare, Agriculture & Environmental Sustainability
Frontiers in Computational Chemistry
Advances in Dye Degradation
Biological and Medical Significance of Chemical Elements
Frontiers In Medicinal Chemistry
Advances in Organic Synthesis
Frontiers in Natural Product Chemistry
Recent Advances in Analytical Techniques
Advanced Catalysts Based on Metal-organic Frameworks (Part 2)
17