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 107
- Downloads 0
Evaluation of Antioxidant Activities and Phenolic Compounds of Scorzonera latifolia (Fisch. & Mey.) DC. Collected from Different Geographic Origins in Turkey
Objectives: The chemical composition of plants is considered to be affected by many parameters. Therefore, the region where the samples are collected is likely to have an influence on the composition of phenolic compoun...
The Influence of Piperine on the Radioprotective Effect of Curcumin in Irradiated Human Lymphocytes
Objectives: Ionizing radiation (IR) induces DNA damage in normal cells, leading to genotoxicity. The radioprotective effects of co-treatment with curcumin and piperine were investigated against genotoxicity induced by IR...
Therapeutic Protection from Hepatic Injury and Chemical Constituents of Buchanania angustifolia Roxb
Objectives: The use of modern medicines in the treatment of diseases instead of traditional medicine is causing different adverse effects. Therefore, there is need to search new bioactive compounds to treat different dis...
Genotype and Allele Frequency of CYP3A4 -392A>G in Turkish Patients with Major Depressive Disorder
Objectives: Genetic polymorphisms may help for individualized drug dosing and improved therapeutics. CYP3A4 is responsible for the metabolism of more than 50% of the commonly used drugs and metabolizes typical antipsych...
Comparative Clinical Study of the Effectiveness of MEKRITEN in Patients with Chronic Suppurative Otitis
Objectives: Chronic suppurative otitis media (CSOM) is a serious disease with the presence of bacterial infection in the middle ear. Worldwide, 1% to 46% of the population living in developed and developing countries ha...