FELODIPINE-REVIEW OF ANALYTICAL METHODS DEVELOPED FOR PHARMACEUTICAL DOSAGE FORMS AND BIOLOGICAL FLUIDS

Authors

  • KIRAN MALLI Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Udupi, Karnataka, India https://orcid.org/0009-0001-6419-4196
  • LALIT KUMAR Department of Pharmaceutics, National Institute of Pharmaceutical Education, Hajipur-844102, Vaishali, Bihar, India https://orcid.org/0000-0002-2418-9712
  • RUCHI VERMA Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Udupi, Karnataka, India https://orcid.org/0000-0002-1279-7243

DOI:

https://doi.org/10.22159/ijap.2023v15i6.49211

Keywords:

Felodipine, Analytical methods, Pharmaceutical dosage forms, Biological fluids

Abstract

Felodipine (FDP) is a vascular selective L-type calcium channel blocker, in hypertension patients FDP significantly lowers systolic and diastolic blood pressure (BP). It is a lipophilic drug molecule that contains a dihydropyridine ring responsible to show pharmacological activity, it is mainly used to control and prevent essential hypertension. This review article provides a summary of various analytical techniques for determining felodipine in pure form, pharmaceutical formulations, and biological fluids. Various analytical techniques are developed and validated, such as ultraviolet/visible spectrophotometry, high-performance liquid chromatography (HPLC), high-performance thin layer chromatography (HPTLC), and bioanalytical techniques. Estimated validation parameters such as linearity, LOD (Limit of Detection), and LOQ (Limit of Quantification) are discussed for each method. The wavelength of detection (λmax), mobile phase, columns, flow rate, retention time (Rt) and sample preparation techniques are all important quality elements for calculating Felodipine via analytical procedures.

Downloads

Download data is not yet available.

Author Biography

LALIT KUMAR, Department of Pharmaceutics, National Institute of Pharmaceutical Education, Hajipur-844102, Vaishali, Bihar, India

Assistant Professor, Department of Pharmaceutics

References

Migliorança LH, Barrientos Astigarraga RE, Schug BS, Blume HH, Pereira AS, De Nucci G. Felodipine quantification in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci. 2005;814(2):217-23. doi: 10.1016/j.jchromb.2004.10.032, PMID 15639442.

Vadlamudi MK, Dhanaraj S. Stability indicating method for the determination of related substances in felodipine solid dosage form and in the drug substance by RP-HPLC. J Bioequiv Availab. 2016;8(4):153-66. doi: 10.4172/jbb.1000287.

Yedinak KC, Lopez LM. Felodipine: a new dihydropyridine calcium-channel antagonist. DICP. 1991 Nov;25(11):1193-206. doi: 10.1177/106002809102501109, PMID 1763537.

Saltiel E, Ellrodt AG, Monk JP, Langley MS. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in hypertension. Drugs. 1988 Oct;36(4):387-428. doi: 10.2165/00003495-198836040-00002, PMID 3069435.

Elmfeldt D, Hedner T, Westerling S. Felodipine in hypertension-a review. J Cardiovasc Pharmacol. 1987 Jan 1;10 Suppl 1:S154-60. doi: 10.1097/00005344-198710001-00028, PMID 2442509.

Ljung B. Vascular selectivity of felodipine: experimental pharmacology. J Cardiovasc Pharmacol. 1990 Jan 1;15Suppl 4:S11-6. doi: 10.1097/00005344-199015004-00003, PMID 1693715.

Edgar B, Lundborg P, Regårdh CG. Clinical pharmacokinetics of felodipine. A summary. Drugs. 1987 Dec;34Suppl 3:16-27. doi: 10.2165/00003495-198700343-00005, PMID 3327676.

Baarnhielm C, Skanberg I, Borg KO. Cytochrome P-450-dependent oxidation of felodipine-a 1,4-dihydropyridine-to the corresponding pyridine. Xenobiotica. 1984 Jan 1;14(9):719-26. doi: 10.3109/00498258409151470, PMID 6516445.

Dunselman PH, Edgar B. Felodipine clinical pharmacokinetics. Clin Pharmacokinet. 1991 Dec;21(6):418-30. doi: 10.2165/00003088-199121060-00003, PMID 1782737.

Mohamed AM, Omar MA, Hammad MA, Mohamed AA. Spectrofluorimetric and micelle-enhanced spectrofluorimetric methods for determination of felodipine and nimodipine in pharmaceutical preparations and human plasma. Spectrochim Acta A Mol Biomol Spectrosc. 2015 Oct 5;149:934-40. doi: 10.1016/j.saa.2015.05.026, PMID 26005990.

Santosh SC, Sandeep SS, Vaibhav PP, Jugal M, Sanjay JK. Development and validation of UV spectrophotometric method for estimation of felodipine using green solvent in tablet formulation. Acta Sci Pharm Sci. 2018;4(2):13-5.

Walash MI, Belal FF, El-Enany NM, El-Maghrabey MH. Synchronous fluorescence spectrofluorimetric method for the simultaneous determination of metoprolol and felodipine in combined pharmaceutical preparation. Chem Cent J. 2011 Dec;5(1):70. doi: 10.1186/1752-153X-5-70, PMID 22059735.

Basavaiah K, Chandrashekar U, Prameela HC. Sensitive spectrophotometric determination of amlodipine and felodipine using iron(III) and ferricyanide. Farmaco. 2003 Feb 1;58(2):141-8. doi: 10.1016/S0014-827X(02)00018-6, PMID 12581780.

Jadhav NR, Kambar RS, Nadaf SJ. Dual wavelength spectrophotometric method for simultaneous estimation of atorvastatin calcium and felodipine from tablet dosage form. Advances in Chemistry. 2014;2014:1-6. doi: 10.1155/2014/131974.

Rajesh K, Rajalakshmi R, Vijayaraj S, Sreelakshmi T. assessment of thiruvarur region groundwater samples using physicochemical parameters. Asian J Res Chem. 2011;4(8):1202-5. doi: 10.5958/0974-4150.

Thorat VM, Pawar SS, Pande VV, Arote SR, Musmade Deepak S. Development and validation of UV spectrophotometric method for estimation of process related impurity in felodipine bulk and formulation. Der Pharm Lett. 2015;7:284-90.

Krishna NM, Rao SS, Rambabu C. Bromothymol blue and bromocresol purple as efficient reagents for the development and validation of visible spectrophotometric assay methods for felodipine. Int Pharm Drug Anal. 2017 Apr 8:108-15.

Gedil F, Ustun O, Atay O. Quantitative determination of felodipine in pharmaceuticals by HPLC and UV spectroscopy. Turk J Pharm Sci. 2004;1(2):65-76.

Nimje HM, Oswal RJ, Kshirsagar SS, Chavan M. Spectrophotometric analysis for estimation of felodipine in tablet dosage form by calibration curve method. Res J Pharm Technol. 2011;4(12):1805-6.

Basavaiah K, Chandrashekar U, Gowda NP. Titrimetric and spectrophotometric assay of felodipine in tablets using bromated-bromide, methyl orange and indigo carmine reagents. J Serb Chem Soc. 2005;70(7):969-78. doi: 10.2298/JSC0507969B.

Patre NG, Patil SS. Development and validation of stability indicating assay method for determination of felodipine in tablet dosage form. Int J Pharm Sci Drug Res. 2018 Jul;10(4):268-73.

Jain PS, Ansari NA, Surana SJ. HPTLC and RP-HPTLC method development and validation for the estimation of felodipine in bulk and pharmaceutical formulation. Pharm Anal Acta. 2018;9:599. doi: 10.4172/2153-2435.1000599.

Migliorança LH, Barrientosastigarraga RE, Schug BS, Blume HH, Pereira AS, Denucci G. Felodipine quantification in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry. Journal of Chromatography B. 2005 Jan 25;814(2):217-23. doi: 10.1016/j.jchromb.2004.10.032.

Strode III JT, Taylor LT, Howard AL, Ip D, Brooks MA. Analysis of felodipine by packed column supercritical fluid chromatography with electron capture and ultraviolet absorbance detection. J Pharm Biomed Anal. 1994 Aug 1;12(8):1003-14. doi: 10.1016/0731-7085(94)00048-4, PMID 7819374.

Walash M, Belal F, El-Enany N, Zayed S. Micellar liquid chromatographic determination of felodipine in tablets and human plasma with fluorescence detection: application to stability studies and content uniformity testing. Anal Methods. 2014;6(10):3401-9. doi: 10.1039/C3AY41570H.

Cardoza RM, Amin PD. A stability indicating LC method for felodipine. J Pharm Biomed Anal. 2002 Feb 1;27(5):711-8. doi: 10.1016/S0731-7085(01)00490-3.

Taha EA, Fouad MM, Attia AK, Yousef ZM. RP-HPLC method development and validation for simultaneous estimation of ramipril and felodipine. Eur J Chem. 2019 Jun 30;10(2):113-7. doi: 10.5155/eurjchem.10.2.113-117.1832.

Bhavana G, Indira PG, Apuroopa. Method development and validation of stability indicating RP-HPLC for the estimation of felodipine PR tablets. Asian J Pharm Anal. 2020;10(4):207-12. doi: 10.5958/2231-5675.2020.00038.1.

Jadhav NR, Kambar RS, Nadaf SJ. Com/storage/app/archive/pdf/AfDLePcalFplIJ4T7fh3Kq4Wku0TzLIhueSZlpJ8. pdf. J Curr Pharm Res. 2012 Jul 1;2(4):637.

Dhale C, Joshi S, Shete S. Development and validation RP-HPLC method for analysis of felodipine in bulk and pharmaceutical dosage form. Int Res J Pharm. 2014;5(10):770-2. doi: 10.7897/2230-8407.0510156.

Patel YP, Patil S, Bhoir IC, Sundaresan M. Isocratic, simultaneous reversed-phase high-performance liquid chromatographic estimation of six drugs for combined hypertension therapy. J Chromatogr A. 1998 Dec 18;828(1-2):283-6. doi: 10.1016/s0021-9673(98)00652-9, PMID 9916313.

Pandey VP, Soma Sekhar K, Shenoy KR. Pharmacology Online. 2010;2:36270.

Madhukar A, Kumar YG, Usha K, Srilatha M. Analytical method development and validation of felodipine in bulk and tablet dosage form by using rp-hplc techniques. Indo Am J Pharmacol Sci. 1;4(9):3248-53. doi: 10.5281/zenodo.987841.

Santhosh Kumar P, Srinivasa Rao V, Abdul K, Prasad UV, Nanda Kumar Y, Sarma PV. J Pharm Res. 2012;5:1838-40.

Hu L, Hu Q, Gao N. Int J Pharm Sci Res. 2013 Sep 1;4(9):3369. doi: 10.13040/IJPSR.0975-8232.4(9).3369-74.

Kallepalli P. A new stability indicating liquid chromatographic method for the quantification of felodipine. Asian J Pharm. 2018 Aug 18;12(02):S597-602. doi: 10.22377/ajp.v12i02.2400.

Basavaiah K, Chandrashekar U, Prameela HC. Determination of felodipine in bulk drug and in tablets by high-performance liquid chromatography. Indian J Chem. 2003;10:454-6.

Jarag RJ, Paradkar AR. Development and validation of method for quantitative estimation of felodipine agglomerates by high pressure liquid chromatography. Asian J Res Chem. 2011;4(1):88-90.

Ahmed S, Atia NN, Ali MF. Ultrasound assisted dispersive liquid-liquid microextraction coupled with high performance liquid chromatography designated for bioavailability studies of felodipine combinations in rat plasma. J Chromatogr B. 2017;1046:200-10. doi: 10.1016/j.jchromb.2017.01.034.

Sakamoto T, Ohtake Y, Itoh M, Tabata S, Kuriki T, Uno K. Determination of felodipine enantiomers using chiral stationary phase liquid chromatography and gas chromatography/mass spectrometry, and the study of their pharmacokinetic profiles in human and dog. Biomed Chromatogr. 1993 Mar;7(2):99-103. doi: 10.1002/bmc.1130070211, PMID 8485383.

Dru JD, Hsieh JY, Matuszewski BK, Dobrinska MR. Determination of felodipine, its enantiomers, and a pyridine metabolite in human plasma by capillary gas chromatography with mass spectrometric detection. J Chromatogr B Biomed Appl. 1995 Apr 21;666(2):259-67. doi: 10.1016/0378-4347(94)00579-t, PMID 7633602.

Kim H, Roh H, Yeom S, Joo Lee H, Beom Han S. Sensitive determination of felodipine in human and dog plasma by use of liquid–liquid extraction and LC–ESI–MS–MS. Chromatographia. 2003 Aug;58(3-4):235-40. doi: 10.1365/s10337-003-0042-6.

Baranda AB, Mueller CA, Alonso RM, Jimenez RM, Weinmann W. Quantitative determination of the calcium channel antagonists amlodipine, lercanidipine, nitrendipine, felodipine, and lacidipine in human plasma using liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2005 Feb 1;27(1):44-52. doi: 10.1097/00007691-200502000-00010, PMID 15665746.

Kim SH, Lee HJ. Development and validation of a high-throughput method for the quantitative analysis of felodipine in human plasma using high-performance liquid chromatography with mass/mass spectrometer and its application to a bioequivalence study in healthy male Korean subjects. J Pharm Investig. 2012 Aug;42(4):177-84. doi: 10.1007/s40005-012-0028-1.

Lindmark B, Ahnoff M, Persson BA. Enantioselective determination of felodipine in human plasma by chiral normal-phase liquid chromatography and electrospray ionisation mass spectrometry. J Pharm Biomed Anal. 2002 Jan 15;27(3-4):489-95. doi: 10.1016/S0731-7085(01)00582-9.

Albu F, Sora I, Tache F, David V, Medvedovici A. On-line SPE on restricted access adsorbent for HPLC-MS/MS analysis of felodipine in plasma samples. Anal Lett. 2010 May 4;43(7-8):1330-43. doi: 10.1080/00032710903518740.

Kallem RR, Ramesh M, Seshagirirao JV. Validated LC-ESI-MS/MS method for simultaneous quantitation of felodipine and metoprolol in rat plasma: application to a pharmacokinetic study in rats. Biomed Chromatogr. 2013 Jun;27(6):784-91. doi: 10.1002/bmc.2861, PMID 23303553.

Li Y, Yin Y, Sun Z, Li X, Hu L, Li P. Sensitive and rapid quantification of felodipine by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) and its pharmacokinetics in healthy chinese volunteer. Chemical Research in Chinese Universities. 2006;22(4):479-83. doi: 10.1016/S1005-9040(06)60146-3.

Nishioka R, Umeda I, Oi N, Tabata S, Uno K. Determination of felodipine and its metabolites in plasma using capillary gas chromatography with electron-capture detection and their identification by gas chromatography-mass spectrometry. J Chromatogr. 1991;565(1-2):237-46. doi: 10.1016/0378-4347(91)80386-q, PMID 1874870.

Gabrielsson M, Hoffmann K, Gunnar Regardh C. Determination of four carboxylic acid metabolites of felodipine in plasma by high-performance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 1992;573(2):265-74. doi: 10.1016/0378-4347(92)80128-D.

Salunkhe NH, Jadhav NR, Bhinge SD. Validated RP-HPLC method for quantification of felodipine in rabbit plasma: application in a bioequivalence study. Ann Pharm Fr. 2019 Jan 1;77(1):15-27. doi: 10.1016/j.pharma.2018.08.002, PMID 30243471.

Kisan Chatki P, Tabassum S. Analytical methods of dihydropyridines based calcium channel blockers–amlodipine, lacidipine, isradipine, nifedipine, felodipine, cilnidipine and its related formulations: a review. AJRC. 2021;14(3):221-34. doi: 10.52711/0974-4150.2021.00039.

Palem CR, Gannu R, Yamsani SK, Yamsani VV, Yamsani MR. Development of a high-performance liquid chromatography method for simultaneous determination of pioglitazone and felodipine in pig serum: application to pharmacokinetic study. Biomed Chromatogr. 2011 Aug;25(8):952-8. doi: 10.1002/bmc.1553, PMID 21058416.

Utpal J, Anjan KM, Sovan LP, Prabal KM, Guru PM. Preparation and in vitro characterization of felodipine loaded eudragit® rs100 nanoparticles. Int J Pharm Pharm Sci. 2014;6(4):564-67.

Raghavendra Rao NG, Kulkarni U, Chitral MS. Comparative study on effect of different techniques used in the formulation of felodipine fast dissolving tablets. Int J Pharm Pharm Sci. 2010;2:152-9.

Keerthana M, Shirisha S, Sahoo Sunit K, Madhusudhan RY. Formulation and evaluation of bilayered felodipine transdermal patches: in vitro and ex vivo characterization. Asian J Pharm Clin Res. 2021;14(3):106-11. doi: 10.22159/ajpcr.2021.v14i3.40290.

Published

07-11-2023

How to Cite

MALLI, K., KUMAR, L., & VERMA, R. (2023). FELODIPINE-REVIEW OF ANALYTICAL METHODS DEVELOPED FOR PHARMACEUTICAL DOSAGE FORMS AND BIOLOGICAL FLUIDS. International Journal of Applied Pharmaceutics, 15(6), 53–59. https://doi.org/10.22159/ijap.2023v15i6.49211

Issue

Section

Review Article(s)