New Validated RP-HPLC Method for Simultaneous Estimation of Valsartan and Nebivolol in Bulk and Dosage Forms
International Research Journal of Pure and Applied Chemistry,
Page 56-65
DOI:
10.9734/irjpac/2021/v22i230386
Abstract
The main reason of this work to develop a sensitive, rapid, economic, precise reverse phase liquid chromatographic method to separate and assay the simultaneous determination of Valsartan and Nebivolol as a minor component in bulk and dosage forms. The separation was carried out using SHIMADZU UV-photo diode array detector at 200, 245 nm for Nebivolol and Valsartan respectively equipped with reverse phase C18 column Sunniest 5μm, 4.6 mm, 250 mm at 40˚C oven temperature, flow rate of 1 mL/min with mobile phase consist of 70:30 methanol: 10 mM phosphate buffer pH=3. The retention time of Nebivolol and Valsartan were to be found at 4.3 min and 8 min respectively. The method was validated according to ICH guidelines. The linearity of the proposed method was investigated in concentration range of 45.8-229% r=0.9997 for Nebivolol and the range 55-166%, r=0.9999 for Valsartan. Robustness in the case of little change of some chromatographic conditions. Validation of the proposed method was carried out for its linearity, accuracy, precision, robustness and assay. This method can be applied easily in routine work analysis to detrmine the estimation of nebivolol and valsartan in bulk and dosage forms.
Keywords:
- Valsartan
- Nebivolol
- RP-HPLC
- Antihypertensive drugs
How to Cite
Albakour, B., Trefi, S., & Bitar, Y. (2021). New Validated RP-HPLC Method for Simultaneous Estimation of Valsartan and Nebivolol in Bulk and Dosage Forms. International Research Journal of Pure and Applied Chemistry, 22(2), 56-65. https://doi.org/10.9734/irjpac/2021/v22i230386
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Kirchhoff C, Bitar Y, Ebel S, Holzgrabe U. Analysis of atropine, its degradation products and related substances of natural origin by means of reversed-phase high-performance liquid chromatography. Journal of Chromatography A. 2004;1046(1-2):115-120..
Siddartha B, Sudheer Babu I, Ravichandra Gupta Ch, Parthiban C. Analytical method development and validation for simultaneous estimation of nebivolol and valsartan in bulk and pharmaceutical dosage form by RP-HPLC method. International Journal of Pharmacy. 2014;4(1):340- 46.
Shinde Vaibhav, Sufiyan Ahmad, Yogesh Patil, Shastry VM, Ansari Sajjad. Analytical method development and validation for the simultaneous estimation of nebivolol and valsartan by RP-HPLC in bulk and tablet dosage forms. Journal of Pharmacy Research. 2017;11(5):472– 78.
Arunadevi S, Birajdar Subramania Nainar Meyyanathan, Bhojraj Suresh. Simultaneous determination of nebivolol HCL and valsartan in solid dosage form by spectrophotometric and RP-HPLC method. International Journal of Pharmaceutical Sciences and Research. 2011;2(2):424-31.
MS Bhatia, Kokil SU. Simultaneous estimation of nebivolol hydrochloride and valsartan using RP HPLC. Indian Journal of Pharmaceutical Sciences. 2009;71(2):111-14.
Accessed: January 10, 2021.
Available:https://go.drugbank.com/drugs/DB00177.
Sweetman SC.. Martindale: The complete drug reference. London: Pharmaceutical Press.
“Nebivolol.” DrugBank Online; 2009.
Accessed: January 10, 2021.
Available:https://go.drugbank.com/drugs/DB04861.
Kachhadia PK, Doshi AS, Joshi HS. Development and validation of a stability-indicating column high-performance liquid chromatographic assay method for determination of nebivolol in tablet formulation. JAOAC. Int. 2008;91(3):557–561.
Shah DA, Bhatt KK, Mehta RS, Baldania SL. Determination of nebivolol hydrochloride and hydrochlorothiazide in tablets by first-order derivative spectrophotometry and liquid chromatography. JAOAC. Int. 2008;5(91):1075–1082.
Rajeswari KR, Sankar GG, Rao AL, Raju DB, Seshagiri Rao. JVLN RP-HPLC method for the estimation of nebivolol in bulk and pharmaceutical dosage form asian. J. Chem. 2005;17(2):1259-1263.
Kamila MM, Mondal N, Ghosh LK, Gupta BK. A validated UV spectrophotometric method for estimation of nebivolol hydrochloride in bulk and pharmaceutical formulation. Pharmazie. 2007;62(7):486- 487.
Reddy TS, Devi PS. Validation of a high-performance thin-layer chromatographic method, with densitometric detection, for quantitative analysis of Nebivolol hydrochloride in tablet formulations. J of Planar Chrom. 2007;20:149- 152.
Sahoo MK, Giri RK, Barik CS, Kanungo SK, Ravi Kumar BVV. RP-HPLC Method for the estimation of nebivolol in tablet dosage form. E-Journal of Chem. 2009;6:915- 919.
Ramakrishna NV, Vishwottam KN, Koteshwara M, Manoj S, Santosh M, Varma DP. Rapid quantification of nebivolol in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J Pharm. Biomed. Anal 2005;39:1006- 1013.
Kokil SU, Bhatia MS. Simultaneous estimation of nebivolol hydrochloride and valsartan using RP-HPLC. Indian Journal of Pharmaceutical Sciences. 2009;71(2):111-114.
Shinde Sachin R, Bhoir Suvarna I, Pawar Namdev S, Yadav Suman B, Ghumatkar Ajay S, Bhagwat Ashok M. Simultaneous determination of valsartan and nebivolol Hcl in tablet dosage form by RP-HPLC. Asian Journal of Research in Chemistry. 2009;2(4):519-522.
Arunadevi S, Birajdar Subramania, Nainar Meyyanathan, Bhojraj Suresh. Simultaneous determination of nebivolol HCL and valsartan in solid dosage form by spectrophotometric and RP-HPLC method. International Journal of Pharmaceutical Sciences and Research. 2011;2(2):424-431.
Meyyanathan SN, Arunadevi S, Birajdar Bhojraj Suresh. Simultaneous estimation of nebivolol hydrochloride and valsartan and nebivolol hydrochloride and hydrochlorothiazide in pharmaceutical formulation by UV spectrophotometric methods. Indian Journal of Pharmaceutical Education and Research. 2010;44(2):156-159.
Jagadish S, Modiya Chirag B, Pandya KP, Channabasavaraj. Simultaneous estimation of nebivolol hydrochloride and valsartan in bulk and capsule dosage form by simultaneous equation method. International Journal of Chem Tech Research. 2010;2(3):1387- 1390.
Koseki N, Kawashita H, Hara H, Niina M, Tanaka M, Kawai R, et al. Development and validation of a method for quantitative determination of valsartan in human plasma by liquid chromatography-tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis. 2007;43(5):1769-1774.
Ediga Sasi Kiran Goud, V Krishna Reddy. RP-HPLC validation of related substances of nebivolol in bulk and 2.5/5/10/20 mg Tablets. International Journal of Pharmaceutical Biological and Chemical sciences. 2012;1(2):11-21.
Sridevi Ramachandran, Badal Kumar Mandal, Sameer. Simultaneous spectrophotometric determination of valsartan and ezetimibe in pharmaceuticals. Tropical Journal of Pharmaceutical Research. 2011;10(6):809-15.
Macek J, Klima J, Ptacek P. Rapid determination of valsartan in human plasma by protein precipitation and HPLC. Journal of Chromatography B. Analytical Technologies in the Biomedical and Life Sciences. 2006;832(1):169- 72.
Patel Satish Ambalal, Patel Hemant M. Development and validation of HPTLC method for simultaneous estimation of nebivolol and hydrochlorthiazide in tablet. International Journal of Pharmaceutical Frontier Research. 2012;2(1):28- 38.
Bitar Y. Separation and assay of three anti-cough drugs pseudoephedrine, dextromethorphan and chlorpheniramine in pharmaceutical forms by using single RP-HPLC METHOD. Research Journal of Pharmacy and Technology. 2020;13(2): 831.
L Huber. Validation and qualification in analytical laboratories, 2nd ed, Informa Healthcare USA; 2007.
Kirchhoff C, Bitar Y, Ebel S, Holzgrabe U. Analysis of atropine, its degradation products and related substances of natural origin by means of reversed-phase high-performance liquid chromatography. Journal of Chromatography A. 2004;1046(1-2):115-120..
Siddartha B, Sudheer Babu I, Ravichandra Gupta Ch, Parthiban C. Analytical method development and validation for simultaneous estimation of nebivolol and valsartan in bulk and pharmaceutical dosage form by RP-HPLC method. International Journal of Pharmacy. 2014;4(1):340- 46.
Shinde Vaibhav, Sufiyan Ahmad, Yogesh Patil, Shastry VM, Ansari Sajjad. Analytical method development and validation for the simultaneous estimation of nebivolol and valsartan by RP-HPLC in bulk and tablet dosage forms. Journal of Pharmacy Research. 2017;11(5):472– 78.
Arunadevi S, Birajdar Subramania Nainar Meyyanathan, Bhojraj Suresh. Simultaneous determination of nebivolol HCL and valsartan in solid dosage form by spectrophotometric and RP-HPLC method. International Journal of Pharmaceutical Sciences and Research. 2011;2(2):424-31.
MS Bhatia, Kokil SU. Simultaneous estimation of nebivolol hydrochloride and valsartan using RP HPLC. Indian Journal of Pharmaceutical Sciences. 2009;71(2):111-14.
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