Development and Validation of a Derivative Spectrophotometric Method for Simultaneous Multicomponent Determination of Levodopa, Carbidopa and Entacapone

Document Type : Research Article

Authors

Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, I.R. IRAN

Abstract

In this study entacapone, levodopa, and carbidopa, were determined with high precision in the presence of each other. UV-VIS spectroscopy was used as an easy and low-cost technique for the analysis and the derivative spectrophotometric method was applied for elimination of absorption interferences. For this purpose, the derivative spectra of each compound were studied separately, and zero crossing points were determined for each of them. The zero-crossing points in which the absorption was observed only for one compound were found and evaluated for quantitative analysis. Calibration curves were drawn from the second and third derivative signals for each compound and the linear range was determined. The method was linear in the range of 1-5 µg/mL for levodopa, 0.25-1.7 µg/mL for carbidopa, and 2-14 µg/mL for entacapone.
The accuracy and precision of the proposed method were evaluated by within-day and between-day tests (CV < 1.56% and error < 1.7%) and finally, these drugs were determined in pharmaceutical dosage forms by the developed method.

Keywords

Main Subjects


[1] Liu, Z., Ma S., Recent Advances in Synthetic α‐Glucosidase Inhibitors, Chem. Med. Chem., 12(11): 819-829 (2017).
[2] Saeedi M., et al., Heterocyclic Compounds: Effective α-Amylase and α-Glucosidase Inhibitors, Current Topics in Medicinal Chemistry, 17(4): 428-440 (2017).
[3] Armstrong M.J., Okun M.S., Diagnosis and Treatment of Parkinson's Disease: A Review Jama, 323(6): 548-560 (2020).
[4] Jankovic Tan J.EK., Parkinson’s Disease: Etiopathogenesis and Treatment, Journal of Neurology, Neurosurgery & Psychiatry, 91(8): 795-808 (2020).
[5] Fabbri M., Ferreira J.J., Rascol O., COMT Inhibitors in the Management of Parkinson’s Disease, CNS Drugs, 1-22 (2022).
[6] Liao X., et al., Levodopa/Carbidopa/Entacapone for the Treatment of Early Parkinson’s Disease: A Meta-Analysis, Neurological Sciences, 41(8): 2045-2054 (2020).
[7] Jiang R., et al., Determination of Levodopa by Chromatography-Based Methods in Biological Samples: A Review, Analytical Sciences, 38(8): 1009-1017 (2022).
[8] Paim, C., et al., Stability-Indication LC Determination of Entacapone in Tablets, Chromatographia,. 65(9): 595-599 (2007).
[9] Salimian M., Sohrabi M.R., Mortazavinik S., Application of Net Analyte Signal and Principal Component Regression for Rapid Simultaneous Determination of Levodopa and Carbidopa in Commercial Pharmaceutical Formulation and Breast (Human) Milk Sample Using Spectrophotometric Method, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 283: 121741 (2022).
[10] Abdel-Ghany M.F., et al., Investigation of Different Spectrophotometric and Chemometric Methods for Determination of Entacapone, Levodopa and Carbidopa in Ternary Mixture, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 171: 236-245 (2017).
[11] Nigović B., New Approach on Sensitive Analysis of Pimavanserin, Levodopa and Entacapone Based on Synergistic Effect Of Graphene Nanoplatelets and Graphitized Carbon Nanotubes in Functionalized Polymer Matrix, Electrochimica Acta, 439: 141700 (2023).
[12] Burmaoğlu R.E.,  Sağlık Aslan S., , A Rapid Liquid Chromatography/Tandem Mass Spectrometry Method for Simultaneous Determination of Levodopa, Carbidopa, Entacapone and Their Six Related Compounds in Film-Coated Tablets, Rapid Comunications on Mass Spectrometry, 34(12): e8782 (2020).
[13] Wollmer E., Klein S., Development and Validation of a Robust and Efficient HPLC Method for the Simultaneous Quantification of Levodopa, Carbidopa, Benserazide and Entacapone in Complex Matrices, Journal of Pharmacy & Pharmaceutical Sciences, 20: 258-269 (2017).
[14] Subramanian V.B., et al., A Simple High‐Performance Liquid Chromatography Method Development for Carbidopa and Levodopa Impurities: Evaluation of Risk Assessment Before Method Validation by Quality by Design Approach, Separation Science Plus, 3(11-12): 530-539 (2020).
[15] Bulduk İ., Gökçe S., Development and Validation of a Effective and Reliable HPLC Method for the Quantification of Levodopa and Carbidopa in Pharmaceutical Formulations, Hacettepe Journal of Biology and Chemistry, 49(4): 413-422 (2021).
[16] Bhatnagar P., et al., Stability Indicating HPLC Method for Simultaneous Estimation of Entacapone, Levodopa and Carbidopa in Pharmaceutical Formulation, J. Chromatogr. Sep. Tech., 6(304): 2 (2015).
 [18] Heydari S., Comparison of Two Liquid-Liquid Microextractions for the Detection of Crocin in the Saffron and Biological Samples Using UV-Vis Spectrophotometry, Iranian Journal of Chemistry and Chemical Engineering (IJCCE), 37(1): 99-108 (2018).
[19] Ghadimloozadeh S., Sohrabi M.R., Fard H.K., Development of Rapid And Simple Spectrophotometric Method for the Simultaneous Determination of Anti-Parkinson Drugs in Combined Dosage form Using Continuous Wavelet Transform and Radial Basis Function Neural Network, Optik, 242:  167088 (2021).
[20] Pagani A.P., CABEZóN M.A., IBáñEZ G.A., Simultaneous Kinetic-Spectrofluorometric Determination of Levodopa and carbidopa Using Partial Least-Squares Regression, Analytical Sciences,. 25(5): 633-638 (2009).
[21] Souri, E., et al., Development of a Rapid Derivative Spectrophotometric Method for Simultaneous Determination of Acetaminophen, Diphenhydramine and Pseudoephedrine in Tablets, Iranian Journal of Pharmaceutical Research: IJPR, 14(2): 435 (2015).
[22] Passos M.L. Saraiva M.L.M., Detection in UV-Visible Spectrophotometry: Detectors, Detection Systems, and Detection Strategies, Measurement, 135: 896-904 (2019).
[23] Verma G., Mishra M., Development and Optimization of UV-Vis Spectroscopy-A Review, World Journal of Pharmaceutical Research, 7(11): 1170-1180 (2018).