Different ratio spectra methods for simultaneous determination of Olmesartan Medoxomil, Hydrochlorothiazide and Amlodipine Besylate
DOI:
https://doi.org/10.56511/JIPBS.2016.v3.i02.pp166-181Abstract
New, simple and specific spectrophotometric methods involving Direct spectrophotometric method ,derivative ratio spectra-zero-crossing method [DRSZ] double divisor ratio spectra derivative method [DDRD], and successive ratio spectra were developed and validated in accordance with ICH guidelines for the simultaneous estimation of Olmesartan Medoxomil [OLM], Amlodipine Besylate [AMLB], and Hydrochlorothiazide [HCTZ] in their combined pharmaceutical dosage form. First, Amlodipine [AMLB] was determined by direct spectrophotometry at 356.0 nm alone without any interference from OLM, and HCTZ. In the DRSZ method OLM, HCTZ, and AMLB were determined at 259.0nm, 279.0nm, and 358.0nm respectively, in the DDRD method OLM, HCTZ, and AMLB were determined at 266.0nm, 317.0nm, and 363.0nm respectively, and in the successive ratio spectra OLM, HCTZ, &AMLB were determined at 239.0nm, 276.0nm, and 375.0nm respectively. The calibration curves are linear over the concentration range of 5-50 µg mL-1 for OLM, HCTZ, and AMLB respectively for all methods. The proposed methods were successfully applied for the assay of the three analytes with excellent recoveries in Laboratory prepared mixtures. No interference was observed from common pharmaceutical additives. The methods are validated according to the ICH guidelines where accuracy, precision and repeatability are found to be within the acceptable limit.
Keywords:
Derivative ratio spectrum zero-crossing method [DRSZ], Double divisor ratio spectra derivative method [DDRD], Successive ratio spectra methodDownloads
References
Moffat AC, Osselton MD and Widdop B: Clarke's Analysis of Drugs and Poisons. Thirdth edition. London: Pharmaceutical Press; 2004.
Koga K, Yamagishi S, Takeuchi M, Inagaki Y, Amano S, Okamoto T, Saga T, Makita Z, and Yoshizuka M: CS-866, a new angiotensin II type 1 receptor antagonist, ameliorates glomerular anionic site loss and prevents progression of diabetic nephropathy in Successive Ratio Spectroscopy method: Inter-day precision % R.S.D. Mean % S.D. % R.S.D. Recovery * 0.539 1.283 99.442 1.275 0.9269 1.279 101.187 1.294 0.303 0.525 95.43 0.501 0.424 1.598 95.422 1.525 1.559 1.651 96.293 1.59 2 99.966 1.904 1.905 0.478 101.576 0.385 0.379 1.212 100.756 1.184 1.175 0.606 98.976 0.878 0.887 0.799 99.626 1.179 1.184 1.942 98.91 1.675 1.693 1.985 97.808 1.501 1.535 0.115 97.275 0.549 0.565 1.605 97.031 1.507 1.553 0.771 97.385 1.008 1.035 Otsuka Long-Evans Tokushima fatty rats. Mol Med 2002; 8:591 – 599.
Schwocho LR, and Masonson HN: Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects. J Clin Pharmacol 2001; 41:515 – 527.
Sweetman SC: Martindale-the Complete Drug Reference. 36th edition. London UK: The Pharmaceutical Press; 2009.
Brunton LL, Chabner BA, and Knollmann BC: Goodman & Gilman's the Pharmacological Basis of Therapeutics. 12th edition. New York: McGraw-Hill; 2010.
The British Pharmacopeia. London: Her Majesty’s Stationery Office; 2010.
United States Pharmacopeia: United States Pharmacopeia. Rockville: United States Pharmacopeial Convention; 2007.
Ma Y, Qin F, Sun X, Lu X and Li F: Determination and pharmacokinetic study of amlodipine in human plasma by UPLCelectrospray ionization spectrometry. J Pharm Biomed Anal, 2007; 43:1540-5.
Rao JS, Rao VJ, Pawar A, and Rao ABNN: A validated method for the simultaneous quantification of hydrochlorothiazide, olmesartan medoxomil and amlodipine in bulk and pharmaceutical dosage form. Journal of Pharmacy Research 2012; 5:43 – 46.
Kumar KK, Rao CK, Madhusudan G, and Mukkanti K: Rapid Simultaneous determination of Olmesartan — Amlodipine and Hydrochlorothiazide in combined pharmaceutical dosage form by stabilityindicating ultra performance liquid chromatography. American Journal of Analytical Chemistry 2012; 3:50 – 58.
Rao JR, Rajput MP, and Yadav SS: Simultaneous quantitation of olmesartan medoxomil, Amlodipine besylate and hydrochlorothiazide in pharmaceutical dosage form by using HPLC. International Journal of Pharm Tech Research 2011; 3:1435 – 1440.
Saminathan J, and Vetrichelvan T: Method development and validation of olmesartan, Amlodipine and hydrochlorothiazide in combined tablet dosage form. International Journal of Pharmaceutical Research & Analysis 2011; 1:7 – 14.
Sharma HK, Jain N, and Jain SK: Development of spectrophotometric method for quantitative estimation of amlodipine besylate, olmesartan medoxomil and hydrochlorthiazide in tablet dosage form. Pharmceutica Analytica Acta 2011; 2:2.
Patel SR, and Patel CN: Development and validation of spectrophotometric method for determination of Olmesartan, amlodipine and hydrochlorothiazide in combined pharmaceutical dosage forms. Novel Science International Journal of Pharmaceutical Science 2012; 1:317 – 321.
Darwish Hany W: Application of smart spectrophotometric methods and artificial neural network for the simultaneous quantitation of olmesartan medoxamil, amlodipine Besylate and hydrochlorothiazide in their combined pharmaceutical dosage form. Chemistry Central Journal 2013; 7:22.
Heilmeyer,and Adam Hilger, Spectrophotometry in Medicine London, 1943; 7.
Glenn. A.L: the importance of extinction ratios in the spectrophotometric analysis of mixtures of two known absorbing substances .J. Pharm. Pharmacol.1960; 12: 595.
Glenn. A.L.: The use of orthogonal functions to correct for irrelevant absorption in two component spectrophotometric analysis. J. Pharm. Pharmacol 1963; 15: 123T-130T
Wahbi A.M., Abdin H., and Korany M.A.: Spectrophotometric determination of chloramphenicol-sulphacetamide in eye drops. Pharmazie 1978; 33:278.
M. A. Korany, M. A. Elsayed, M.M Bedair, Mahgoub H, Korany E.A.: Computer assisted spectrophotometry: multicomponent analysis with a discrete fourier transform Talanta 1990; 37(12): 347.
Shibata. S., Furukawa M., and Goto K.: Dualwavelength spectrophotometry. The determination of mixtures, Anal. Chim. Acta.1971; 53:369.
Shibata S., Gote, and Ishiguro Y.: Dualwavelength spectrophotometry — part III. Determination of arsenazo I in arsenazo III, Anal. Chim. Acta. 1972; 62:305.
Wahbi AM, and Farghaly AM.: Application of the delta-A method to the determination of morphine. J. Pharm. Pharmacol. 1970; 22:848.
Wahbi A.M., Abdine H., Korany M.A., and El Yazbi F.A.: Spectrophotometric analysis of binary mixtures of antazoline and naphazoline. J. Pharm. Sci. 1978; 67:140.
Tahboud Y.R.,and Pardue H.L.: Evaluation of multiwavelength firstand secondderivative spectra for the quantitation of mixtures of polynuclear aromatic hydrocarbons. Anal. Chem. 1985; 57:38.
Rossi D.T., and Pardue H.L.: Effects of wavelength range on the simultaneous quantitation of polynuclear aromatic hydrocarbons with absorption spectra. Anal. Chim. Acta. 1985; 175:153.
Dinc E, Yucesoy C and Onur F: Simultaneous spectrophotometric determination of mefenamic acid and paracetamol in a pharmaceutical preparation using ratio spectra derivative spectrophotometry and chemometric methods. J. Pharm. Biomed. Anal. 2002; 28:1091-1100.
Blanco M., Gene J., Iturriaga H., Maspoch S.,and Riba J.: Diode-array detectors in flow-injection analysis Mixture resolution by multi-wavelength analysis. Talanta 1978; 34:987 .
Verdu-Andres J., Bosch-Reig F., and Campins-Falco P.: H-point Standard Additions Methods for Analyte Determination in Ternary Mixtures. Analyst 1988; 113:1011.
Verdu-Andres. J., Bosch-Reig. F., and Compins-Falco P: H-point standard additions method for analyte determination in ternary mixture. Analyst 1995; 120:299.
Salinas.F., Berzas Nevado J.J., and Epsinosa. M.A.: A new spectrophotometric method for quantitative multicomponent analysis resolution of mixtures of salicylic and salicyluric acids.Talanta1990; 37:347.
Berzas Nevado JJ, Guiberteau Cabanillas C,and Salinas F.: Spectrophotometric resolution of ternary mixtures of salicylaldehyde, 3-hydroxybenzaldehyde and 4-hydroxybenzaldehyde by the derivative ratio spectrum-zero crossing method. Talanta 1992; 39:547-53.
Onur F, Yucesoy C, Dermis S, Katral M and Kukdil G.: Simultaneous determination of pseudoephedrine sulfate, dexbrompheniramine maleate and loratadine in pharmaceutical preparations. Talanta 2000; 51: 269-279.
H. Mahgoub, A.A. Gazy, F. El-Yazbi, M.A. ElSayed, and R.M. Youssef: Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1 receptor antagonists using derivative ratio spectrum method, J. Pharm. Biomed. Anal. 2003; 31:801.
Dinç E,and Onur F: Application of a new spectrophotometric method for the analysis of a ternary mixture containing metamizol, paracetamol and caffeine in tablets. Anal Chim Acta. 1998; 359:93-106.
Dinç E1: The spectrophotometric multicomponent analysis of a ternary mixture of ascorbic acid, acetylsalicylic acid and paracetamol by the double divisor-ratio spectra derivative and ratio spectra-zero crossing methods.Talanta 1999; 48:1145.
Dinç E1, Baydan E, Kanbur M, and Onur F: Spectrophotometric multicomponent determination of sunset yellow, tartrazine and allura red in soft drink powder by double divisor-ratio spectra derivative, inverse least-squares and principal component regression methods. Talanta 2002; 58:579.
Wahbi Abdel-Aziz M. and Mahgoub H.: Application of Fourier functions to ratiospectra of absorption curves: Theory and application. Bull. Fac. Cairo Univ. 2003; 41: 265.
Mahgoub H., Gazy Azza A., El-Yazbi Fawzi A., Mahmoud A. ElSayed and Youssef Rasha M.: Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1-receptor antagonists using derivative ratio spectrum method. J. Pharm. Biomed. Anal. 2003; 31:801.
Dinç E1, and Onur F: Application of a new spectrophotometric method for the analysis of a ternary mixture containing metamizol, paracetamol and caffeine in tablets. Anal. Chim. Acta 1998; 359:93.
Dinç E1: The spectrophotometric multicomponent analysis of a ternary mixture of ascorbic acid, acetylsalicylic acid and paracetamol by the double divisorratio spectra derivative and ratio spectrazero crossing methods.Talanta1999; 48: 1145.
Dinç E1, Baydan E, Kanbur M,and Onur F: Spectrophotometric multicomponent determination of sunset yellow, tartrazine and allura red in soft drink powder by double divisor-ratio spectra derivative, inverse least-squares and principal component regression methods. Talanta 2002; 58:579.
Mahgoub H.: Spectrophotometric resolution of the binary mixture nadolol and bendroflumethiazide in pharmaceutical tablets. Bull. Fac. Cairo Univ. 2003; 41:285.
Afkhami A., and Bahram M.: Mean centering of ratio spectra as a new spectrophotometric method for the analysis of binary and ternary mixtures. Acta Part A 2005; 61:869.
Afkhami A., and Bahram M.: Mean centering of ratio spectra as a new spectrophotometric method for the analysis of binary and ternary mixtures. Talanta2005; 66:712.
W.A. Petri, J.G. Hardman, L.E. Limbird, A.G. Gilman (Eds.), Goodman, and Gilman’s: The Pharmacological Basis of Therapeutics, McGraw-Hill, New York, 2001; pp.1273.
M. A. Kamyabi: Simultaneous Spectrophotometric Determination of Paracetamol and p-Aminophenol by Using Mean Centering of Ratio Kinetic Profiles. J. Chin. Chem. Soc. 2009; 56:142.
Panchagnula R., Sood A., Sharda N., Kaur K.,and Kaul C.L.: Determination of rifampicin and its main metabolite in plasma and urine in presence of pyrazinamide and isoniazid by HPLC method. J. Pharm. Biomed. Anal. 1998 ;18: 1013.
Calleri E1, De Lorenzi E, Furlanetto S, Massolini G, and Caccialanza G: Validation of a RP-LC method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin in a pharmaceutical formulation. J. Pharm. Biomed. Anal. 2002; 29:1089.
Afkhami Abbas, and Bahram Morteza: Successive ratio-derivative spectra as a new spectrophotometric method for the analysis of ternary mixtures.Journal of Spectrochimica Acta Part A 2005; 61: 869 – 877.
Bonazzi D., Gooti R., Andrisano V. and Cavrini B.: Analysis of ACE inhibitors in pharmaceutical dosage forms by derivative UV spectroscopy and liquid chromatography (HPLC). Journal of Pharm Biomed Anal. 1997; 16:431-8.
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