Merugu Manasa, Vijey Aanandhi M
Merugu Manasa1, Vijey Aanandhi M2*
1Research Scholar, Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India.
2Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India.
Volume - 14,
Issue - 3,
Year - 2021
A New specific, economic and selective, accurate, precise and robust Reverse Phase High Performance Liquid Chromatography was developed for the quantification of Semaglutide in pharmaceutical substance and product. Chromatographic separation was achieved by C18 column (Azilent C18 150x 4.6, 5mm) is used as stationary phase and 0.01N Potassium dihyrogen ortho phosphate: Acetonitrile (50:50) used as a mobile phase at a flow rate of 1.0 mL/min and monitored at 230nm. The run time was 5min. The retention time of Semaglutide was found to be 2.222min. To fulfil the International Conference on Harmonisation requirements developed method was validated. Validation parameters include system suitability, specificity, linearity, accuracy, precision, intermediate precision and robustness. Calibration curve was linear over the concentration range of 7-42 µg/ml. From regression analysis relative correlation coefficient (R2) value was found to be 0.999. Accuracy and precision results were within the limits. LOD and LOQ were found to be 0.007 µg/ml and 0.022 µg/ml respectively. Semaglutide was subjected to the stress conditions like acidic, basic, oxidative, photolytic and thermal conditions. In acidic, alkaline and peroxide stress conditions. In acidic, alakaline and oxidative conditions degradant peaks were observed but there is no interference with semaglutide peak in all accelerated conditions, hence proving the stability indicating and specific nature of method. Assay result was found to be 99.99% W/W, thus it is proving that the method can also be applied for the estimation of Semaglutide in pharmaceutical drug product.
Cite this article:
Merugu Manasa, Vijey Aanandhi M. Stability Indicating Method Development and Validation of Semaglutide by RP-HPLC in Pharmaceutical substance and Pharmaceutical Product. Research J. Pharm. and Tech 2021; 14(3):1385-1389. doi: 10.5958/0974-360X.2021.00247.X
1. Validation of Analytical Procedures Text and Methodology. Q2 (R1) 1994; Current step 4 version.
2. Blessy Mn, et. all, Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis 2014;4(3):159–165.
3. Available at http://webstore.idex-hs.com/techinfo/hplcIntro.asp.
4. Available at https://www.drugbank.ca/drugs/DB13928.
5. Available at https://pubchem.ncbi.nlm.nih.gov/compound/ Semaglutide # section=Structures.
6. Arun Kumar Kuna, S. Ganapaty and G. V. Radha, Analytical method development and validation for the estimation of belinostat in pharmaceutical formulation by RP-HPLC. International Journal of Research in Pharmaceutical Sciences 10(2):865-873.
7. Subha Harika Penmetsa and Raja Sundararajan. Method development and validation of RP-UPLC method for the determination of semaglutide in bulk and pharmaceutical dosage form. International Journal of Research and Analytical Reviews. 2018; 5(4): 534-543.
8. Subha Harika Penmetsa and Raja Sundararajan. Method development and validation of semaglutide by UV spectrophotometric method in bulk and pharmaceutical dosage form. International Journal of Research and Analytical Reviews. 2019; 6(2): 394-402.