SIMPLE AND RAPID HPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF LEVODOPA AND CARBIDOPA IN A FAST DISINTEGRATING TABLET FORMULATION

  • Shohreh Alipour Department of Quality Control, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran,
  • MAHSA ASEF Department of Quality Control, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
  • FATEMEH AHMADI Research Center for Nanotechnology in Drug Delivery, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

Objective: Fast disintegrating tablets (FDTs) are found helpful in dysphagia (difficulty in swallowing) especially in Parkinson patients. Levodopa is still the first choice in Parkinson disease treatment and is co-administered by carbidopa for better efficacy.


Methods: In the present study, a rapid and simple isocratic Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for simultaneous quantification of levodopa and carbidopa in optimized Fast Disintegrating Tablets (FDTs). The linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ) of the method were determined. FDTs were prepared using direct compression, dry and wet granulation and were optimized for faster disintegration time. Tablets thickness, weight, hardness, friability, drug content and dissolution profile were also evaluated.


Results: A RP-HPLC system with C18 column and mobile phase 90:10 (v/v) phosphate buffer: methanol was used. The method linearity was found to be within the concentration range of 3.125-50 μg/ml for levodopa, and 3.125-25 μg/ml for carbidopa. The intra and inter-day precision and accuracy were acceptable. LOD and LOQ of levodopa-carbidopa were 0.2-0.8 μg/ml and 0.5-2.4 μg/ml, respectively. The total chromatographic run time was 5 min. The optimized FDTs hardness was 3.81±0.4 and tablets were disintegrated within 30 sec. Levodopa and carbidopa were dissolved in dissolution media within 5 min.


Conclusion: Results indicated that this method was suitable for simultaneous quantification of levodopa and carbidopa in the presence of different ingredients of a pharmaceutical solid dosage form. Therefore, this method could be applied in pharmaceutical quality control for rapid quantification of structurally similar substances with different physicochemical properties.

Keywords: High Performance Liquid Chromatography, Levodopa, Carbidopa, Fast Disintegrating Tablets

References

1. S Sharma, S Lohan, RS Murthy. Formulation and characterization of intranasal mucoadhesive nano particulates and thermo-reversible gel of levodopa for brain delivery. Drug Dev Ind Pharm 2014;40:869-78.
2. J Goole, Amighi K. Levodopa delivery systems for the treatment of Parkinson's disease: an overview. Int J Pharm 2009;380:1-15.
3. R Bettini, D Acerbi, G Caponetti, R Musa, N Magi, P Colombo, et al. Influence of layer position on in vitro and in vivo release of levodopa methyl ester and carbidopa from three-layer matrix tablets. Eur J Pharm Biopharm 2002;53:227-32.
4. D Satyanarayana, K Keshavarao. Fast disintegrating films containing anastrozole as a dosage form for dysphagia patients. Arch Pharm Res 2012;35:2171-82.
5. K Chaitanya, S Velmurugan. Formulation and evaluation of levodopa effervescent floating tablets. In J Pharm Pharm Sci 2015;7:189-93.
6. S Mohammed, SK Sharma, K Kaucha, D Hiremath. Formulation and evaluation of flurbiprofen fast disintegrating tablets using natural superdisintegrants. Asian J Pharm Clin Res 2016;9:247-54.
7. Vineet Bhardwaj, M Bansal, PK Sharma. Formulation and evaluation of fast dissolving tablets of amlodipine besylate using different super disintegrants and camphor as sublimating agent. Am-Eurasian J Sci Ress 2010;5:264-9.
8. Modasiya MK, Lala II, Prajapati BG, PVM, SDA. Design and characterization of fast disintegrating tablets of piroxicam.?Int J PharmTech Res 2009;1:353-7.
9. J Goole, K Amighi. Levodopa delivery systems for the treatment of Parkinson's disease: an overview. Int J Pharm 2009;380:1-15.
10. HM Tawfeek, Faisal W. Enalapril maleate orally disintegrating tablets: Tableting and in vivo evaluation in hypertensive rats. Pharm Dev Technol 2018;23:496-503.
11. C Patil, S Das. Effect of various superdisintegrants on the drug release profile and disintegration time of lamotrigine orally disintegrating tablets. Afr J Pharm Pharmacol 2011;5:76-82.
12. S Alipour, S Akbari, F Ahmadi. Development and in vitro evaluation of fast-dissolving oral films of ondansetron hydrochloride. Trends Pharm Sci 2015;1:25-30.
13. Y Fu, S Yang, SH Jeong, S Kimura, K Park. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004;21:433-76.
14. H Goel Rai, Parshuram Rana, Vikas Tiwary, Ashok K. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Delivery Formulation 2008;2:258-74.
15. K Plachka, L Chrenkova, M Dousa, L Novakova. Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities. J Pharm Biomed Anal 2016;125:376-84.
16. O Vilhena Rde, FL Pontes, BM Marson, RP Ribeiro, KA de Carvalho, MA Cardoso, et al. A new HILIC-MS/MS method for the simultaneous analysis of carbidopa, levodopa, and its metabolites in human plasma. J Chromatogr B Anal Technol Biomed Life Sci 2014;967:41-9.
17. J Chi, Y Ling, R Jenkins, F Li. Quantitation of levodopa and carbidopa in rat plasma by LC-MS/MS: the key role of ion-pairing reversed-phase chromatography. J Chromatogr B Anal Technol Biomed Life Sci 2017;1054:1-9.
18. FM Heliana, Douglas Pinto, Viviane de A, Nascimento Marlice, AS Marques, Fabio Amendoeira. Determination of levodopa in human plasma by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS): application to a bioequivalence study. Quim Nova 2013;36:171-6.
19. K Chun, YH Lee, KE Lee, HS Gwaka. Design and evaluation of levodopa methyl ester intranasal delivery systems. Parkinson's Dis 2011;1:101-7.
20. PP Raut, SY Charde. Simultaneous estimation of levodopa and carbidopa by RP-HPLC using a fluorescence detector: its application to a pharmaceutical dosage form. Luminescence 2014;29:762-71.
21. P Bhatnagar, D Vyas, S Sinha, T Chakrabarti. Stability indicating HPLC method for simultaneous estimation of entacapone, levodopa and carbidopa in pharmaceutical formulation. J Chromatogr Sep Tech 2015;6. Doi: 10.4172/2157-7064.1000304
22. RF Donnelly. Stability of levodopa/carbidopa rectal suspensions. Hosp Pharm 2016;51:915-21.
23. K Chun, YH Lee, KE Lee, HS Gwaka. Design and evaluation of levodopa methyl ester intranasal delivery systems. J Parkinson’s Dis 2011;1:101-7.
24. H Goel, P Rai, V Rana, AK Tiwary. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Delivery Formu 2008;2:258-74.
25. S Alipour, Parhizkar, Elahehnaz Haleh, Farrahi, Ahmadi, Fatemeh. Formulation and in vitro evaluation of taste-masked fast disintegrating tablets of prednisolone. Lat Am J Pharm 2017;36:980-6.
26. L Winarti, L Ameliana, D Nurahmanto. Formula optimization of orally disintegrating tablet containing meloxicam nanoparticles. Indonesian J Pharm 2017;28:53-64.
27. DM Shinkar, Pooja S, Aher Parag, D Kothawade, AD Maru. Formulation and invitro evaluation of fast dissolving tablet of verapamil hydrochloride. In J Pharm Pharm Sci 2018;10:93-9.
28. D Sharma. Formulation development and evaluation of fast disintegrating tablets of salbutamol sulphate for respiratory disorders. Int Scholar Res Notice Pharm 2013;2013:674507.
29. D Sharma, Singh G, Kumar D, Singh M. Formulation development and evaluation of fast disintegrating tablets of salbutamol sulphate, cetirizine hydrochloride in combined pharmaceutical dosage form: a new era in novel drug delivery for pediatrics and geriatrics. J Drug Delivery 2015;2015:1-10.
30. Nadia H Naiem, Ebtessam A Essa, GM Elmaghraby. Enhancing dissolution rate of indomethacin by in situ crystalization: development of orally disintegrating tablets. In J Pharm Pharm Sci 2018;10:18-23.
31. USP Convention. U. S. Pharmacopeia-National Formulary. New York: United States Pharmacopeia; 2016.
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Alipour, S., ASEF, M., & AHMADI, F. (2019). SIMPLE AND RAPID HPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF LEVODOPA AND CARBIDOPA IN A FAST DISINTEGRATING TABLET FORMULATION. International Journal of Applied Pharmaceutics, 11(3), 200-205. https://doi.org/10.22159/ijap.2019v11i3.30676
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