Advanced spectrophotometric methods for quantitative assessment of two antihypertensive drugs in mixture with hydrochlorothiazide in pure form and pharmaceutical formulations
Tóm tắt
Labetalol (Lab) and nebivolol (Neb) are β-adrenoceptor blocking agents that are employed for control of hypertension alone or co-administered with hydrochlorothiazide (HCTZ) as a potent diuretic for synergistic antihypertensive effect. Advanced, accurate and simple spectrophotometric methods with minor manipulation of zero-order spectra were suggested for simultaneous quantitation of Lab or Neb in mixture with HCTZ for quality control purpose in pure form and pharmaceutical formulations. These methods include (a) constant center method, (b) advanced absorbance subtraction method for Lab and HCTZ, (c) absorption factor method (AFM) and (d) the ratio subtraction method. The established methods were successfully applied over concentration ranges 10–100 µg/mL, 10–75 µg/mL and 2.5–25 µg/mL of Lab, Neb and HCTZ, respectively. Results were compared statistically to those of official and reported methods revealing no remarkable difference. Validation of methods followed international conference of harmonization guidelines. Suggested methods require minor processing of zero-order spectra with accurate results that facilitate the quantitative estimation of studied mixtures in quality control laboratories.
Tài liệu tham khảo
A.M. Sambrook, R.C. Small, The treatment of hypertension in pregnancy. Anaesth. Intensive Care Med. 9, 128–131 (2008). https://doi.org/10.1016/j.mpaic.2008.01.008
A. Joel, N. Shantaram, C. Naresh, Formulation and evaluation of controlled release tablets of labetalol hydrochloride using hydrophobic polymers. Int. J. Res. Pharm. Biomed. Sci. 4, 380–384 (2013). https://doi.org/10.13179/canchemtrans.2013.01.01.0014
P. Lukkari, T. Nyman, M.L. Riekkola, Determination of nine β-blockers in serum by micellar electrokinetic capillary chromatography. J. Chromatogr. A 674, 241–246 (1994). https://doi.org/10.1016/0021-9673(94)85229-4
A. Witek, H. Hopkala, G. Matysik, TLC-densitometric determination of bisoprolol, labetalol and propafenone, as dabsyl derivatives in pharmaceutical preparations. Chromatographia 50, 41–44 (1999). https://doi.org/10.1007/BF02493615
H. Zhao, H. Li, Z. Qiu, Separation of enantiomeric labetalol by reverse-phase high-performance liquid chromatography. Chin. J. Chromatogr. 17, 369–371 (1999)
C. Ceniceros, M.I. Maguregui, R.M. Jimenez, R.M. Alonso, Quantitative determination of the β-blocker labetalol in pharmaceuticals and human urine by high-performance liquid chromatography with amperometric detection. J. Chromatogr. B 705, 97–103 (1998). https://doi.org/10.1016/S0378-4347(97)00492-1
M. Delamoye, C. Duvernewil, F. Paraire, P. de Mazancourt, J.C. Alvarez, Simultaneous determination of thirteen β blockers and one metabolite by gradient high-performance liquid chromatography with photodiode-array detection. Forensic Sci. Int. 141, 23–31 (2004). https://doi.org/10.1016/j.forsciint.2003.12.008
A. Changchit, J. Gal, J.A. Zirrolli, Stereospecific gas chromatographic/mass spectrometric assay of the chiral labetalol metabolite 3-amino-1-phenylbutane. Biol. Mass Spectrom. 20, 751–758 (1991). https://doi.org/10.1002/bms.1200201202
S. Carda-Broch, R. Rapado-Martinez, I. Esteve-Romero, M.C. Garcia-Alverez-Coque, Analysis of urine samples containing cardiovascular drugs by micellar liquid chromatography with fluorimetric detection. J. Chromatogr. Sci. 37, 93–102 (1999). https://doi.org/10.1093/chromsci/37.4.93
C. Karlsson, H. Wikstrom, D.D. Armstrong, P.K. Owens, Enantioselective reversed-phase and non-aqueous capillary electrochromatography using a teicoplanin chiral stationary phase. J. Chromatogr. A 897, 349–363 (2000). https://doi.org/10.1016/S0021-9673(00)00805-0
M.Y. Salem, N.Y. Hassan, Y.M. Fayez, S.A. Sabour, E.S. Ali, Stability-indicating methods for determination of hydrochlorothiazide in combination with some antihypertensive in the presence of its main impurities. JICS (2019). https://doi.org/10.1007/s13738-019-01593-7
D.R. El-Wasseef, S.M. El-Ashry, M.A. Abu-El-Enein, M.A.A. Moustafa, Spectrofluorimetric determination of labetalol in pharmaceutical preparations and biological fluids. J. Food Drug Anal. 14, 133–140 (2006). https://doi.org/10.6227/jfda
F. Belal, S. Al-Shaboury, A.S. Al-Tamrah, Spectrofluorometric determination of labetalol in pharmaceutical preparations and spiked human urine through the formation of coumarin derivative. J. Pharm. Biomed. Anal. 30, 1191–1196 (2002). https://doi.org/10.1016/S0731-7085(02)00471-5
N. Rahman, S.K. Haque, Spectrofluorimetric determination of labetalol hydrochloride in pharmaceutical preparations and urine samples. Int. J. Biomed. Anal. 4, 140–146 (2008)
M.A. Iorio, A. Mazzeo-Farina, A. Doldo, Quantitative analysis of β-adrenergic blocking agents by NMR spectroscopy. J. Pharm. Biomed. Anal. 5, 1–10 (1987). https://doi.org/10.1016/0731-7085(87)80002-X
E. Gorodkiewicz, P. Falkowski, A. Sankiewicz, Z. Figaszewski, Analytical applications of electrode sensitive to labetalol in pharmaceuticals. Cent. Eur. J. Chem. 1, 242–259 (2003). https://doi.org/10.2478/BF02476227
A. Radi, Z. El-Sherif, A. Wassel, Voltammetric determination of labetalol in pharmaceuticals and spiked human urine. Chem. Pap. 58, 242–246 (2004)
S. Jana, P. Jozef, Determination of some cardiovascular drugs in serum and urine by capillary isotachophoresis. J. Chromatogr. A 735, 403–408 (1996). https://doi.org/10.1016/0021-9673(95)00722-9
T.V. Goel, J.G. Nikelly, R.C. Simpson, B.K. Matuszewski, Chiral separation of labetalol stereoisomers in human plasma by capillary electrophoresis. J. Chromatogr. A 1027, 213–221 (2004). https://doi.org/10.1016/j.chroma.2003.08.082
S.L. Tamisier-Karolak, M.A. Stenger, A. Bommart, Enantioseparation of β-blockers with two chiral centers by capillary electrophoresis using sulfated β-cyclodextrins. Electrophoresis 20, 2656–2663 (1999). https://doi.org/10.1002/(SICI)1522-2683(19990901)20:13<2656::AID-ELPS2656>3.0.CO;2-6
A.G. Gilman, T.W. Rall, A.S. Nies, P. Taylor (eds.), The Pharmacological Basis of Therapeutics, 8th edn. (Pergamon Press, Oxford, 1990), p. 286, 847
Y. Gupta, A. Shrivastava, D. Duggal, A. Patel, S. Agrawal, A new RP-HPLC method for simultaneous estimation of nebivolol hydrochloride and hydrochlorothiazide in dosage forms. J. Young Pharm. 1(3), 264–269 (2009). https://doi.org/10.4103/0975-1483.57078
A. Manzoor, Y.N. Manohara, M.C. Ravi, Development and validation of RP-HPLC method for simultaneous estimation of nebivolol hydrochloride and hydrochlorothiazide in combined tablet dosage form. Int. J. ChemTech Res. 4(1), 328–336 (2012)
S.A. Patel, H.M. Patel, Development and validation of HPTLC method for simultaneous estimation of nebivolol and hydrochlorothiazide in tablet. IJPFR 2(1), 28–38 (2012)
P.S. Tarte, S.P. Wate, P.B. Khedikar, B.T. Sapture, G. Pawnikar, Simultaneous estimation of nebivolol and hydrochlorothiazide in combined tablet dosage form by multicomponent mode of analysis. Asian J. Res. Chem. 1(2), 77–79 (2008)
K. Shah, T.R. Desai, A. Behera, R.S. Pal, K.M. Girhepunje, Development of spectrophotometric methods for estimation of nebivolol hydrochloride and hydrochlorothiazide simultaneously, in bulk and tablet dosage form. Res. J. Pharm. Biol. Chem. Sci. 1(2), 451–457 (2010)
K.V. Shah, P.R. Tirgar, D.B. Sheth, T.R. Desai, Simultaneous estimation of nebivolol hydrochloride and hydrochlorothiazide in bulk and in a tablet dosage form by multicomponent and simultaneous estimation method. Int. J. Pharm. 2(1), 27–35 (2011)
R.K. Patel, J.B. Patel, Simultaneous equation spectrophotometric method for the estimation of nebivolol HCl and hydrochlorothiazide in their combined dosage form. IRJPAS 2(1), 6–10 (2011)
R.K. Patel, J.B. Patel, Absorbance ratio spectrophotometric method for the estimation of nebivolol Hcl and hydrochlorothiazide in their combined dosage form. IJAPBC 1(4), 496–502 (2012)
S.C. Sweetman, Martindale: The Complete Drug Reference, 36th edn. (The Pharmaceutical Press, London, 2009), pp. 1307–1311
S.T. Kumbhar, G.K. Chougule, V.S. Tegeli, G.B. Gajeli, Y.S. Thorat, U.S. Shivsharan, A validated HPTLC method for simultaneous quantification of nebivolol and hydrochlorothiazide in bulk and tablet formulation. IJPSDR 3(1), 62–66 (2011)
P.S. Tarte, S.P. Wate, A.V. Bondre, G.V. Paunikar, Simultaneous determination of nebivolol and hydrochlorothiazide in tablet dosage form by RP-HPLC. Int. J. PharmTech Res. 1(3), 720–724 (2009)
D. Ivanović, M. Medenica, B. Jančić, N. Knežević, A. Malenović, J. Milić, Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities. Acta Chromatogr. 18, 143–156 (2007)
N.H. Foda, O. Naeem, A. Abd Elbary, G. Abd Elbary, Simultaneous HPLC determination of enalapril and hydrochlorothiazide in human plasma and its pharmacokinetic application. Int. J. Pharm. Sci. Res. 2(11), 786–794 (2010)
M.A. Hegazy, F.H. Metwaly, M. Abdelkawy, N.S. Abdelwahab, Validated chromatographic methods for determination of hydrochlorothiazide and spironolactone in pharmaceutical formulation in presence of impurities and degradants. J. Chromatogr. Sci. 49(2), 129–135 (2011). https://doi.org/10.1093/chrsci/49.2.129
M.A. Obando, J.M. Estela, V. Cerdà, Simultaneous determination of hydrochlorothiazide and losartan potassium in tablets by high-performance low-pressure chromatography using a multi-syringe burette coupled to a monolithic column. Anal. Bioanal. Chem. 391(6), 2349–2356 (2008)
D. Tian, X. Tian, T. Tian, Z. Wang, F. Mo, Simultaneous determination of valsartan and hydrochlorothiazide in tablets by RP-HPLC. Indian J. Pharm. Sci. 70(3), 372–374 (2008). https://doi.org/10.4103/0250-474X.43006
The United States Pharmacopoeia (USP 40), National Formulary (NF 35), the United States Pharmacopeial Convention, Rockville, MD, USA (2017)
A.T. Hemke, M.V. Bhure, K.S. Chouhan, K.R. Gupta, S.G. Wadodkar, UV spectrophotometric determination of hydrochlorothiazide and olmesartan medoxomil in pharmaceutical formulation. J. Chem. 7(4), 1156–1161 (2010)
C. Vetuschi, A. Giannandrea, G. Carlucci, P. Mazzeo, Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry. IL Farmaco 60, 665–670 (2005). https://doi.org/10.1016/j.farmac.2005.04.013
M.E. Martin, O.M. Hernandez, A.I. Jimenez, J.J. Arias, F. Jimenez, Partial least-squares method in analysis by differential pulse polarography. Simultaneous determination of amiloride and hydrochlorothiazide in pharmaceutical preparations. Anal. Chim. Acta 381(2–3), 247–256 (1999). https://doi.org/10.1016/s0003-2670(98)00732-6
H.M. Lotfy, determination of simvastatin and ezetimibe in combined tablet dosage forms by constant center spectrophotometric method. Int. J. Pharm. Pharm. Sci. 4(4), 673–679 (2012)
H.M. Lotfy, S.S. Saleh, Recent development in ultraviolet spectrophotometry through the last decade (2006–2016): a review. Int. J. Pharm. Pharm. Sci. 8(10), 40–56 (2016)
H.M. Lotfy, M.A. Hegazy, M.R. Rezk, Y.R. Omran, Comparative study of novel versus conventional two-wavelength spectrophotometric methods for analysis of spectrally overlapping binary mixture. Spectrochim. Acta Part A 148, 328–337 (2015)
J.P. Prajapati, M.B. Patel, R.J. Prajapati, N.A. Prajapati, Simultaneous determination of perindopril erbumine and amlodipine besylate by absorption factor method. Int. J. Appl. Biol. Pharm. Technol. 2(3), 230–233 (2011)
S.S. Saleh, H.M. Lotfy, N.Y. Hassan, M. El Gizawy, A comparative study of validated spectrophotometric and TLC- spectrodensitometric methods for the determination of sodium cromoglicate and fluorometholone in ophthalmic solution. SPJ 21, 411–421 (2013)
H.M. Lotfy, H.H. Mounir, A. Abd-Elaleem, Quantitative analysis of the cholesterol-lowering drugs ezetimibe and simvastatin in pure powder, binary mixtures, and a combined dosage form by spectrophotometry, chemometry, and high-performance column liquid chromatography. AOAC 93, 1844–1855 (2010)
M.F. El-Bardicy, M.G. Lotfy, H.M. El Sayed, Smart stability-indicating spectrophotometric methods for determination of binary mixtures without prior separation. AOAC 91, 299–310 (2008)
H.M. Lotfy, S.M. Amer, H.E. Zaazaa, N.S. Mostafa, Spectrophotometric methods for quantitative determination of binary mixture of naproxen sodium and domperidone maleate. Austin J. Anal. Pharm. Chem. 2(3), 1044–1052 (2015)
ICH Validation of analytical procedures: text and methodology Q2 (R1), International Conference on Harmonization, 2005