DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF FELODIPINE IN TABLET DOSAGE FORM
Abstract
A simple and sensitive, HPTLC method has been developed for the quantitative estimation of felodipine in it’s single component tablet formulation. The separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using n -hexane: ethyl acetate in the ratio of 6:4 (v/v) as mobile phase. Felodipine showed Rf value of 0.53 ± 0.027 and was scanned at 366 nm using Camag TLC Scanner 3. The linear regression data for the calibration plot showed a good relationship with r=0.9792. The method was validated for precision and recovery. The limits of detection and quantification were 23.54 and 71.33 ng/spot respectively. The developed method was successfully used for the assay of felodipine tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.
Keywords:
Stability indicating, thin layer chromatography, Felodipine, 1,4-Dihydro pyridine.DOI
https://doi.org/10.25004/IJPSDR.2018.100409References
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12. Dhale C, Joshi S, Shete S. Development & RP- HPLC Method for analysis of Felodipine in bulk and pharmaceuticals. Int. Res. J. Pharm. 2014; 5(10): 770-772.
13. Setti A, Phazna D, Pawar S. Method Development, Validation and stability studies of Felodipine by RP-HPLC and molecular interaction studies of Foledipine and Vpltage Gated L-type calcium channel Int. J Pharm. Sci. Rev Res. 2013;24(3):15-20.
14. Vadlamudi MK, Dhanaraj S. Stability Indicating Method for the determination of related substance in Felodipine solid dosage form and in drug substance by RP-HPLC. J Bioequiv Aavailab. 2016; 8(4):153-166.
15. Zhang N, Yu LJ, Li J, Tong JW, Meng J. Analysis and evaluation of the impurity of felodipine and its tablets. Yao Xue Xue Bao. 2012; 47:223-228.
16. Strode JT, Taylor LT, Howard AL. Analysis of felodipine by packed column supercritical fluid chromatography with electron capture and ultraviolet absorbance detection. J.Pharm Biomed Anal.1994; 12:1003-1014.
17. Renger B, Vegh Z, Fodor F. Valadation of Thin Layer and high performance thin layer chromatographic methods.J. Chromatogr. A. 2011; 1218:2712-2721.
18. Shirode AR, Jadhav BG, Kadam VJ. HPTLC Method Development and Validation of Zolpidem Tartrate in Bulk and Marketed Formulation. Int. J. Pharm. Sci. Drug Res. 2015; 7(2): 193-197.
19. Mohamed AM, Omar MA, Hammad MA, Mohamed AA. Development & validation of TLC-densitomeric method for simultaneous determination of two binary antihypertensive mixtures containing felodipine. Biomedical Chromatography. 2016; 30:200-207.
20. Rao JR. HPTLC method development and validation for simultaneous estimation of Metoprolol succinate and Felodipine in bulk drugs and combined dosage form. Int J Pharma Bio Sci.2018; 9 (2):1-7.
2. Borow KM, Neumann A, Wynne J. Sensitivity of endsystolic Pressure dimension and pressure-volume relations to the inotropic state in humans Circulation. 1982; 65: 988-97.
3. Bostrom SL. Ljung B, Mardh S, Forsen S, Thulin E. Interaction of the antihypertensive drug felodipine with calmodulin. Nature. 1981; 292: 777-778.
4. Culling W, Ruttley MS, Sheridan DJ. Acute haemodynamic effects of felodipine during beta-blockade in patients with coronary artery disease. Br. Heart J.1984; 52: 431-434.
5. Dillon MJ. Investigation and management of hypertension in children. Pediatr Nephrol. 1987; 1: 59-68.
6. Fleckenstein A. Specific pharmacology of calcium in myocardium, cardiac pacemakers and vascular smooth muscle. Annu Rev Pharmacol Toxicol. 1977; 17: 1496
7. Cardoza RM. A stability indicating LC method for felodipine. J.Pharm Biomed Anal. 2002; 27:711-718
8. Basvaiah K, Chandrashekar U, Prameela HC. Deterrmination of felopidine in Bulk drug &in tablets by HPLC. Indian Journal of Chemical Technology. 2003; 10: 454-456.
9. Gedil F, Ustun O, Atay O. Quantitative determination of Felodipine in pharmaceuticals by HPLC & UV spectroscopy. Turkish J. Pharm. Sci. 2004;2: 65-76
10. Nataraj S, Kumar K, Suresh S, Duza M, Badrud K. Method validation and estimation of felodipine in pure and capsule dosage form by RP-HPLC. Journal of Pharmacy Research 2011; 4:2822.
11. Annapurna MM, Pavan Kumar BS, Goutam SVS, Stability indicating RP-HPLC method for determination felodipine in tablets. Indo American Journal of Pharmaceutical Research. 2013; 11:9277-85.
12. Dhale C, Joshi S, Shete S. Development & RP- HPLC Method for analysis of Felodipine in bulk and pharmaceuticals. Int. Res. J. Pharm. 2014; 5(10): 770-772.
13. Setti A, Phazna D, Pawar S. Method Development, Validation and stability studies of Felodipine by RP-HPLC and molecular interaction studies of Foledipine and Vpltage Gated L-type calcium channel Int. J Pharm. Sci. Rev Res. 2013;24(3):15-20.
14. Vadlamudi MK, Dhanaraj S. Stability Indicating Method for the determination of related substance in Felodipine solid dosage form and in drug substance by RP-HPLC. J Bioequiv Aavailab. 2016; 8(4):153-166.
15. Zhang N, Yu LJ, Li J, Tong JW, Meng J. Analysis and evaluation of the impurity of felodipine and its tablets. Yao Xue Xue Bao. 2012; 47:223-228.
16. Strode JT, Taylor LT, Howard AL. Analysis of felodipine by packed column supercritical fluid chromatography with electron capture and ultraviolet absorbance detection. J.Pharm Biomed Anal.1994; 12:1003-1014.
17. Renger B, Vegh Z, Fodor F. Valadation of Thin Layer and high performance thin layer chromatographic methods.J. Chromatogr. A. 2011; 1218:2712-2721.
18. Shirode AR, Jadhav BG, Kadam VJ. HPTLC Method Development and Validation of Zolpidem Tartrate in Bulk and Marketed Formulation. Int. J. Pharm. Sci. Drug Res. 2015; 7(2): 193-197.
19. Mohamed AM, Omar MA, Hammad MA, Mohamed AA. Development & validation of TLC-densitomeric method for simultaneous determination of two binary antihypertensive mixtures containing felodipine. Biomedical Chromatography. 2016; 30:200-207.
20. Rao JR. HPTLC method development and validation for simultaneous estimation of Metoprolol succinate and Felodipine in bulk drugs and combined dosage form. Int J Pharma Bio Sci.2018; 9 (2):1-7.
Published
01-07-2018
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“DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF FELODIPINE IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 10, no. 4, July 2018, pp. 268-73, https://doi.org/10.25004/IJPSDR.2018.100409.
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How to Cite
“DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF FELODIPINE IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 10, no. 4, July 2018, pp. 268-73, https://doi.org/10.25004/IJPSDR.2018.100409.
