QUANTIFICATION OF VALSARTAN IN TABLETS BY VALIDATED UV-SPECTROPHOTOMETRIC METHOD
Keywords:
Valsartan, UV-spectrophotometry, tablets, determination
Abstract
Angiotensin receptor blocker Valsartan is approved for treatment of I and II stage of hypertension. The aim of current study was the application of the validated UV-spectrophotometric method for determination of Valsartan by the external standard method in pharmaceutical dosage preparations (tablets) in 99.98 % ethanol at λmax = 252 nm and in methanol at λmax = 250 nm. UV-VIS diode array spectrophotometer was used.
Data for Chauvenet’s criterion are lower than maximum permissible value (U = 1.73; N = 6), which is applied for the assessment of the need for the removal of sharply different results. All of the experimental results suit the respective confidence intervals. The analytical parameter repeatability for tablets is characterized by the uncertainty of the result, which includes standard deviation, relative standard deviation and confidential interval. All of the experimental results correspond to the respective confidence intervals at the confidence probability 98 %: Valsartan 160 mg tabl. (99.98 % ethanol): 159.69 mg ¸ 160.37 mg; Valsartan 160 mg tabl. (methanol): 158.51 mg ¸ 160.73 mg. Relative error is lower than 0.25 %.
The validated method can be applied for the determination of Valsartan in pharmaceutical dosage forms.
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References
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5. Majahalme S.K., Baruch L., Aknay N., Goedel-Meinen L., Hofmann M., Hester A., Prescott M.F., Feliciano N. Comparison of treatment benefit and outcome in women versus men with chronic heart failure (from the Valsartan Heart Failure Trial). Amer. J. Cardiol., 2005; 95(4): 529-532.
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11. Bhanushali S.M., Daniel P.S., Anand I.S., Patel C.N., Bhatt P.A., Parikh K.H. A comparative study on efficacy of angiotensin receptor blocker in acute coronary syndrome patients following medicated and non-medicated stent implantation. J. Global Pharma Technol., 2010; 2(3): 98-106.
12. Monteiro P., Duarte A.I., Gonçalves L.M., Providência L.A. Valsartan improves mitochondrial function in hearts submitted to acute ischemia Eur. J. Pharmacol., 2005; 518(2-3): 158-164.
13. Prasuna N.V., Kumar R.K., Damodharam T. Selective spectrophotometric determination of fluoride in water samples using an Alizarin red S complex as a colored reagent. IJRDO J. Applied Sci., 2015; 1(8): 18-32.
14. Zalov A.Z., Amanullayeva G.I. Spectrophotometric determination of cobalt (II) in a liquid-liquid extraction system containing 2-hydroxy-5-iodothiophenol and diphenylguanidine. IJRDO J. Applied Sci., 2016; 2(7): 17-25.
15. Verdizade N.A., Kuliev K.A., Alieva K.R. Extractive spectrophotometric determination of iron (III) with 5-(p-hydroxybenzylidene)-thiazolidone-2,4. IJRDO J. Applied Sci., 2016; 2(11): 18-27.
16. Verdizadeh N.A., Zalov A.Z., Abaskuliyeva U.B., Ephendiyeva N.N., Hasanova N.C. Liquid-liquid extraction and spectrophotometric determination of cromium (VI) with o-hydroxythiophenols in the presence of hydrophobic amines. IJRDO J. Applied Sci., 2017; 3(5): 66-76.
17. Zalov A.Z., Verdizadeh N.A., Aliyev S.G., Mammadova S.A. Extraction and spectropho-tometric determination of tantalum (V) with 2-hydroxythiophenol and its derivatives in the presence of hydrophobic amines. IJRDO J. Applied Sci., 2016; 2(7): 26-37.
18. Thomachan S., Sindhu S., John V.D. Biochemical activities of Curcuminoid analogues with methyl substituted phenyl ring and their transition metal chelates. IJRDO J. Applied Sci., 2015; 1(8): 33-47.
19. Boakye S., Jonfia-Essien W., Voegborlo B.R, Boadi N.O. Assessment of organochlorine pesticides in cocoa beans from Ashanti and Brong Ahafo regions of Ghana. IJRDO J. Applied Sci., 2016; 2(11): 7-19.
20. Momoh H., Idris M.M., Adoum O.A. Evaluation of the antimicrobial and cytotoxic effect of Dendranthema indicum (L Desmoul) leave extract. IJRDO J. Applied Sci., 2017; 3(6): 12-19.
21. Momoh H., Dambata, M.B., Tahir M.T. Phytochemical studies, antimicrobial and antituberculosis evaluation of extracts from the stem bark of Psorospermum senegalense (Spach). IJRDO J. Applied Sci., 2017; 3(6): 3-11.
22. Tatar S., Serap S. Comparison of UV- and second derivative-spectrophotometric and LC methods for the determination of Valsartan in pharmaceutical formulation. J. Pharm. Biomed. Anal., 2002; 30(2): 371-375.
23. Dinc E., Uslu B., Ozkan S.A. Spectral resolution of binary mixture containing Valsartan and Hydrochlorothiazide in tablets by ratio spectra derivative and inverse least squares techniques. Anal. Lett., 2004; 37(4): 679-693.
24. Deshpande M.M., Ahajan M.P., Sawant S.D. Simultaneous estimation of Valsartan and Hydrochlorothiazide in fixed dose combination in UV spectrophotometry. Inter. J. Pharm. Sci., 2012; 3(1): 235-240.
25. Jadhav M.L., Girase M.V., Tidme S.K., Junagade M.S. Development and validation of spectro-photometric methods for simultaneous estimation of Valsartan and Hydrochlorothiazide in tablet dosage form. Int. J. Spectroscopy, 2014; 2014(1): 1-6.
26. Mohamed N.G. Simultaneous determination of Amlodipine and Valsartan. Anal. Chem. Insights, 2011; 6(1): 53-59.
27. Rani P.J., Mounika P., Akifulhaque M, Sireesha D., Harshini S.,Vasudha B. Development and validation of analytical method for the simultaneous estimation of of Amlodipine and Valsartan in bulk and pharmaceutical dosage form by UV-spectrophotometric method. Int. J. Innov. Pharm. Sci. Res., 2015; 3(10): 1513-1520.
28. Damle M.C., Singh S.M., Khetre A.B., Darekar R.S. Spectrophotometric methods for simultaneous estimation of Ramipril and Valsartan in combined tablet dosage form. Anal. Chem. Ind. J., 2008; 7(8): 591-594.
29. Stolarczyk M., Apola A., Maślanka A., Kwiecien A., Opoka W. Spectrophotometric method for simultaneous determination of valsartan and substances from the group of statins in binary mixtures. Acta Pharm., 2017; 67: 463-478.
30. Eissa M.S., Al-Alamein A.M.A. Innovative spectrophotometric methods for simultaneous estimation of the novel two-drug combination: Sacubitril/Valsartan through two manipulation approaches and a comparative statistical study. Spectrochim. Acta A: Mol. Biomol. Spectrosc., 2018; 193: 365-374.
31. Anandakumar K., Jayamariappan M. Absorption correction method for the simultaneous estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in bulk and in combined tablet dosage form. Int. J. Pharm. Pharm. Sci., 2011; 3(1): 23-27.
32. Jothieswari D., Anandakumar K., Vijaya S.D, Vijayakumar B, Priya D, Rathinaraj S.B. Validated UV Spectrophotometric Method for the Simultaneous Estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in bulk and in combined tablet dosage Form. J. Pharm. Biomed. Sci., 2010; 5(5): 1-5.
33. Lotfy HM, Hegazy MA, Mowaka S, Mohamed EH. Novel spectrophotometric methods for simultaneous determination of Amlodipine, Valsartan and Hydrochlorothiazide in their ternary mixture. Spectrochim. Acta A: Mol. Biomolecul. Spectrosc., 2015; 140: 495-508.
34. Kus S., Marczenko Z., Obarski N. Derivative UV-VIS spectrophotometry in analytical chemistry. Chern. Anal. Warsaw, 1996; 41(1): 899-927.
35. Tsvetkova D., Ivanova St. Estimation of validation parameters of UV-Spectrophotometric method for analysis of Valsartan. J. Adv. Pharm. Edu. Res., 2018; 8(3): 37-42.
36. Tsvetkova D., Ivanova S. Investigation and estimation of spectrophotometric values specific and molar absorbances for Losartan Potassium and Valsartan. IJRDO - J Appl. Sci., 2018; 4(9): 13-20.
37. Tsvetkova D., Ivanova S. Application of UV-spectrophotometric method for determination of Losartan Potassium in tablets. Indo Amer. J. Pharm, Sci, 2018; 5(8): 8393-8401.
38. Tsvetkova D., Obreshkova D., Ivanova St, Yankov V., Atanasov P., Hadjieva B. Telmisartan quality control by validation of UV-spectrophotometric method. Int. J. Innov. Res. Med. Sci., 2016; 1(4 : 113-123.
39. Shrivastava A., Gupta V.B. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron.Young Sci. 2011;2(1): 21-25.
40. International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human use, ICH harmonized tripartite Guideline, Validation of Analytical procedures Text and methodology Q2 (R1), 2005.
2. Julius S., Weber M.A., Kjeldsen S.E., McInnes G.T., Zanchetti A., Brunner H.R., Laragh J., Schork M.A., Hua T.A., Amerena J., Balazovjech I., Cassel G., Herczeg B., Koylan N., Mago-metschnig D., Majahalme S., Martinez F., Oigman W., Gomes R.S., Zhu J.R. The Valsartan antihypertensive long-term use evaluation (VALUE) trial: outcomes in patients receiving monotherapy. Hypertens., 2006; 48(3): 385-391.
3. Kimura Y., Kitagawa K., Oku N., Kajimoto K., Kato H., Tanaka M., Sakaguchi M., Hougaku H., Sakoda S., Hatazawa J. Blood pressure lowering with Valsartan is associated with maintenance of cerebral blood flow and cerebral perfusion reserve in hypertensive patients with cerebral small vessel disease. J. Stroke Cerebrovasc. Disease, 2010; 19(2): 85-91.
4. Delea T.E., Thomas S.K., Moynihan A., Frech F., Oster G. Valsartan versus Lisinopril or Metoprolol to prevent cardiovascular events in patients with hypertension. Amer. J. Hypertens., 2005; 18(5) (Suppl. 1): A55-A56.
5. Majahalme S.K., Baruch L., Aknay N., Goedel-Meinen L., Hofmann M., Hester A., Prescott M.F., Feliciano N. Comparison of treatment benefit and outcome in women versus men with chronic heart failure (from the Valsartan Heart Failure Trial). Amer. J. Cardiol., 2005; 95(4): 529-532.
6. Kai H., Mizuta Y., Imaizumi T. Effects of Valsartan on myocardial fibrosis and diastolic dysfunction in hypertensives. CVD Prevent. Control., 2009; 4(Suppl. 1): S128-S129.
7. Solomon S.D., Skali H., Anavekar N.S., Bourgoun M., Barvik S., Ghali J.K., Warnica J.W., Khrakovskaya M., Arnold J.M., Schwartz Y., Velazquez E.J., Califf R.M., McMurray J.V., Pfeffer M.A. Changes in ventricular size and function in patients treated with Valsartan, Captopril, or both fter myocardial infarction. Circulation, 2005; 111(25): 3411-3419.
8. Janardhanan R., Daley W.L., Naqvi T.Z., Mulvagh S.L., Aurigemma G., Zile M., Arnold J.M.O., Artis E., Purkayastha S., Thomas J.D., Solomon S.D. Rationale and design: the VALsartan In Diastolic Dysfunction (VALIDD) Trial: evolving the management of diastolic dysfunction in hypertension. Amer. Heart. J., 2006; 152(2): 246-252.
9. Khaodhiar L., Brennan A.M., Lima C., Chan J.L., Mantzoros C.S., Manning W.J., Danias P.G., Veves A. Effect of Valsartan on left ventricular anatomy and systolic function and aortic elasticity. Metabolism., 2009; 58(5): 682-686.
10. Yasunari K., Maeda K., Watanabe T., Nakamura M., Yoshikawa Y., Asada A. Comparative effects of Valsartan versus Amlodipine on left ventricular mass and reactive oxygen species formation by monocytes in hypertensive patients with left ventricular hypertrophy. ACC Curr. J. Rev., 2004; 13(9): 25-26.
11. Bhanushali S.M., Daniel P.S., Anand I.S., Patel C.N., Bhatt P.A., Parikh K.H. A comparative study on efficacy of angiotensin receptor blocker in acute coronary syndrome patients following medicated and non-medicated stent implantation. J. Global Pharma Technol., 2010; 2(3): 98-106.
12. Monteiro P., Duarte A.I., Gonçalves L.M., Providência L.A. Valsartan improves mitochondrial function in hearts submitted to acute ischemia Eur. J. Pharmacol., 2005; 518(2-3): 158-164.
13. Prasuna N.V., Kumar R.K., Damodharam T. Selective spectrophotometric determination of fluoride in water samples using an Alizarin red S complex as a colored reagent. IJRDO J. Applied Sci., 2015; 1(8): 18-32.
14. Zalov A.Z., Amanullayeva G.I. Spectrophotometric determination of cobalt (II) in a liquid-liquid extraction system containing 2-hydroxy-5-iodothiophenol and diphenylguanidine. IJRDO J. Applied Sci., 2016; 2(7): 17-25.
15. Verdizade N.A., Kuliev K.A., Alieva K.R. Extractive spectrophotometric determination of iron (III) with 5-(p-hydroxybenzylidene)-thiazolidone-2,4. IJRDO J. Applied Sci., 2016; 2(11): 18-27.
16. Verdizadeh N.A., Zalov A.Z., Abaskuliyeva U.B., Ephendiyeva N.N., Hasanova N.C. Liquid-liquid extraction and spectrophotometric determination of cromium (VI) with o-hydroxythiophenols in the presence of hydrophobic amines. IJRDO J. Applied Sci., 2017; 3(5): 66-76.
17. Zalov A.Z., Verdizadeh N.A., Aliyev S.G., Mammadova S.A. Extraction and spectropho-tometric determination of tantalum (V) with 2-hydroxythiophenol and its derivatives in the presence of hydrophobic amines. IJRDO J. Applied Sci., 2016; 2(7): 26-37.
18. Thomachan S., Sindhu S., John V.D. Biochemical activities of Curcuminoid analogues with methyl substituted phenyl ring and their transition metal chelates. IJRDO J. Applied Sci., 2015; 1(8): 33-47.
19. Boakye S., Jonfia-Essien W., Voegborlo B.R, Boadi N.O. Assessment of organochlorine pesticides in cocoa beans from Ashanti and Brong Ahafo regions of Ghana. IJRDO J. Applied Sci., 2016; 2(11): 7-19.
20. Momoh H., Idris M.M., Adoum O.A. Evaluation of the antimicrobial and cytotoxic effect of Dendranthema indicum (L Desmoul) leave extract. IJRDO J. Applied Sci., 2017; 3(6): 12-19.
21. Momoh H., Dambata, M.B., Tahir M.T. Phytochemical studies, antimicrobial and antituberculosis evaluation of extracts from the stem bark of Psorospermum senegalense (Spach). IJRDO J. Applied Sci., 2017; 3(6): 3-11.
22. Tatar S., Serap S. Comparison of UV- and second derivative-spectrophotometric and LC methods for the determination of Valsartan in pharmaceutical formulation. J. Pharm. Biomed. Anal., 2002; 30(2): 371-375.
23. Dinc E., Uslu B., Ozkan S.A. Spectral resolution of binary mixture containing Valsartan and Hydrochlorothiazide in tablets by ratio spectra derivative and inverse least squares techniques. Anal. Lett., 2004; 37(4): 679-693.
24. Deshpande M.M., Ahajan M.P., Sawant S.D. Simultaneous estimation of Valsartan and Hydrochlorothiazide in fixed dose combination in UV spectrophotometry. Inter. J. Pharm. Sci., 2012; 3(1): 235-240.
25. Jadhav M.L., Girase M.V., Tidme S.K., Junagade M.S. Development and validation of spectro-photometric methods for simultaneous estimation of Valsartan and Hydrochlorothiazide in tablet dosage form. Int. J. Spectroscopy, 2014; 2014(1): 1-6.
26. Mohamed N.G. Simultaneous determination of Amlodipine and Valsartan. Anal. Chem. Insights, 2011; 6(1): 53-59.
27. Rani P.J., Mounika P., Akifulhaque M, Sireesha D., Harshini S.,Vasudha B. Development and validation of analytical method for the simultaneous estimation of of Amlodipine and Valsartan in bulk and pharmaceutical dosage form by UV-spectrophotometric method. Int. J. Innov. Pharm. Sci. Res., 2015; 3(10): 1513-1520.
28. Damle M.C., Singh S.M., Khetre A.B., Darekar R.S. Spectrophotometric methods for simultaneous estimation of Ramipril and Valsartan in combined tablet dosage form. Anal. Chem. Ind. J., 2008; 7(8): 591-594.
29. Stolarczyk M., Apola A., Maślanka A., Kwiecien A., Opoka W. Spectrophotometric method for simultaneous determination of valsartan and substances from the group of statins in binary mixtures. Acta Pharm., 2017; 67: 463-478.
30. Eissa M.S., Al-Alamein A.M.A. Innovative spectrophotometric methods for simultaneous estimation of the novel two-drug combination: Sacubitril/Valsartan through two manipulation approaches and a comparative statistical study. Spectrochim. Acta A: Mol. Biomol. Spectrosc., 2018; 193: 365-374.
31. Anandakumar K., Jayamariappan M. Absorption correction method for the simultaneous estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in bulk and in combined tablet dosage form. Int. J. Pharm. Pharm. Sci., 2011; 3(1): 23-27.
32. Jothieswari D., Anandakumar K., Vijaya S.D, Vijayakumar B, Priya D, Rathinaraj S.B. Validated UV Spectrophotometric Method for the Simultaneous Estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in bulk and in combined tablet dosage Form. J. Pharm. Biomed. Sci., 2010; 5(5): 1-5.
33. Lotfy HM, Hegazy MA, Mowaka S, Mohamed EH. Novel spectrophotometric methods for simultaneous determination of Amlodipine, Valsartan and Hydrochlorothiazide in their ternary mixture. Spectrochim. Acta A: Mol. Biomolecul. Spectrosc., 2015; 140: 495-508.
34. Kus S., Marczenko Z., Obarski N. Derivative UV-VIS spectrophotometry in analytical chemistry. Chern. Anal. Warsaw, 1996; 41(1): 899-927.
35. Tsvetkova D., Ivanova St. Estimation of validation parameters of UV-Spectrophotometric method for analysis of Valsartan. J. Adv. Pharm. Edu. Res., 2018; 8(3): 37-42.
36. Tsvetkova D., Ivanova S. Investigation and estimation of spectrophotometric values specific and molar absorbances for Losartan Potassium and Valsartan. IJRDO - J Appl. Sci., 2018; 4(9): 13-20.
37. Tsvetkova D., Ivanova S. Application of UV-spectrophotometric method for determination of Losartan Potassium in tablets. Indo Amer. J. Pharm, Sci, 2018; 5(8): 8393-8401.
38. Tsvetkova D., Obreshkova D., Ivanova St, Yankov V., Atanasov P., Hadjieva B. Telmisartan quality control by validation of UV-spectrophotometric method. Int. J. Innov. Res. Med. Sci., 2016; 1(4 : 113-123.
39. Shrivastava A., Gupta V.B. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron.Young Sci. 2011;2(1): 21-25.
40. International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human use, ICH harmonized tripartite Guideline, Validation of Analytical procedures Text and methodology Q2 (R1), 2005.
Published
2019-02-11
How to Cite
Tsvetkova, D. D., Obreshkova, D. P., & Yankov, V. P. (2019). QUANTIFICATION OF VALSARTAN IN TABLETS BY VALIDATED UV-SPECTROPHOTOMETRIC METHOD. IJRDO-Journal of Applied Science, 5(2), 15-23. https://doi.org/10.53555/as.v5i2.2646
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