Simultaneous Estimation of Saxagliptin and Dapagliflozin in Human Plasma by Validated High Performance Liquid Chromatography - Ultraviolet Method
Journal Title: Turkish Journal of Pharmaceutical Sciences - Year 2019, Vol 16, Issue 2
Abstract
Objectives: The fixed dose combination of saxagliptin and dapagliflozin is a recently approved antidiabetic medication. It is marketed under the brand name Qtern. The aim of this study was to develop a simple, rapid, sensitive, and validated isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of saxagliptin and dapagliflozin in human plasma using linagliptin as internal standard as per US-Food and Drug Administration guidelines. Materials and Methods: The method was performed on a Waters 2695 HPLC equipped with a quaternary pump. The analyte separation was achieved using an Eclipse XDB C18 (150 × 4.6 mm × 5 µm) column with a mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile (50:50) with pH adjusted to 5.0 at 1 mL/min flow rate. Results: The analyte was detected at 254 nm. The retention time of the internal standard, saxagliptin, and dapagliflozin was 2.746, 5.173, and 7.218 min, respectively. The peaks were found to be free of interference. The method was validated over a dynamic linear range of 0.01 to 0.5 μg/mL and 0.05 to 2 μg/mL for saxagliptin and dapagliflozin, respectively, with a correlation coefficient of 0.998. The precision and accuracy of samples of six replicate measurements at lower limits of quantification level were within the limits. The analytes were found to be stable in human plasma at -28°C for 37 days. Conclusion: The stability, sensitivity, specificity, and reproducibility of this method make it appropriate for the determination of saxagliptin and dapagliflozin in human plasma.
Authors and Affiliations
Sharmila DONEPUDI, Suneetha ACHANTA
Keywords
Related Articles
- EP ID EP548519
- DOI 10.4274/tjps.galenos.2018.46547
- Views 116
- Downloads 0
Investigation of Gelatinase Gene Expression and Growth of Enterococcus faecalis Clinical Isolates in Biofilm Models
Objectives: Enterococcus faecalis is the major reason for biofilm-related infections and it also interacts with Staphylococcus aureus in biofilms. Gelatinase (gelE) enzyme is an important virulence factor of E. faecalis...
Synthesis and Swelling Behavior of Sodium Alginate/Poly(vinyl alcohol) Hydrogels
Objectives: Hydrogels are macromolecular networks able to absorb and release water/biological fluids in a reverse-phase manner, in response to specific environmental stimuli. Such stimuli-sensitive behavior makes hydroge...
Real-time Analysis of Impedance Alterations by the Effects of Vanadium Pentoxide on Several Carcinoma Cell Lines
Objectives: Vanadium compounds have various pharmacologic effects and all available evidence reveals that the effects of vanadium compounds depend on many factors, mainly on the type of cells and dose. The proapoptotic o...
Spectrophotometric Quantification of Anti-inflammatory Drugs by Application of Chromogenic Reagents
Objectives: Simple, specific, accurate, precise, sensitive, and cost effective spectrophotometric methods were developed and validated for quantification of the drugs lornoxicam (LOR) and mesalamine (MES) in pure form an...
An Overview of iQOS® as a New Heat-Not-Burn Tobacco Product and Its Potential Effects on Human Health and the Environment
Tobacco smoke from regular cigarettes contains a number of harmful chemicals such as nicotine, arsenic, benzene, carbon monoxide, heavy metals, and tobacco-derived nitrosamines. About 1% of over 7000 chemical substances...