R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa
R. Anantha Kumar1*, G. Raveendra Babu2, M. Sowjanya3, M. Ramayyappa2
1Assistant Professor, Nova College of Pharmacy, Jangareddy gudem, Andhra Pradesh, India.
2A.K.R.G. College of Pharmacy, Nallajerla, Andhra Pradesh, India.
3Vijaya Teja Degree College, Addanki, Andhra Pradesh, India.
Volume - 14,
Issue - 3,
Year - 2021
The intention of this work is to develop a rapid, precise, accurate and sensitive reverse phase liquid chromatographic technique for the simultaneous estimation of Nebivolol and Valsartan in tablet dosage form. The chromatographic method was standardized using Inertsil ODS column (250×4.6mm, 5µm particle size) with UV detection at 278nm and flow rate of 1ml/min. The mobile phase comprises of ACN: Buffer (pH adjusted to 3.5 with dilute Ortho Phosphoric acid) in the fraction of 60:40 v/v. The linearity of proposed method was investigated in the range of 12.5-62.5µg/ml (R²=0.999) for Nebivolol and 200-1000µg/ml(R²=0.999) for Valsartan duly. The limit of detection (LOD) was found to be 0.05µg/ml and 0.81µg/ml for Nebivolol and Valsartan duly. The limit of quantification (LOQ) was found to be 0.15µg/ml and 2.44µg/ml for Nebivolol and Valsartan respectively. The retention time of Nebivolol and Valsartan were ground in to be 4.400min and 2.568min respectively. The method was authentically suggested and % RSD was ground in to be less than 2 indicating high degree of accuracy and precision. Hence proposed method can be successfully graded for the simultaneous estimation of Nebivolol and Valsartan in marketed formulation.
Cite this article:
R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa. Validated RP-HPLC method for the estimation of nebivolol hydrochloride and valsartan in combined tablet dosage form. Asian Journal of Research in Chemistry. 2021; 14(3):168-2. doi: 10.52711/0974-4150.2021.00031
R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa. Validated RP-HPLC method for the estimation of nebivolol hydrochloride and valsartan in combined tablet dosage form. Asian Journal of Research in Chemistry. 2021; 14(3):168-2. doi: 10.52711/0974-4150.2021.00031 Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-3-3
1. Chate PU, Kalshetti MS and Patil RY. Development and Validation of HPLC method for simultaneous estimation of Valsartan and Nebivolol in the dosage. International J. of Pharmaceutical Analysis. 2017; 4(4): 2395-2466.
2. Dabhade B. Development and validation of RP- HPLC for the simultaneous estimation of Nebivolol and Valsartan in bulk and combined tablet dosage form. World Journal of Pharmaceutical Research. 2017; 6(5): 1284-1310.
3. Sivakamasundari G and Kannappanet N. Analytical methodologies for determination of Valsartan: An overview. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6(9): 605-617.
4. Maslarska M. A High-Performance Liquid Chromatographic method with ultraviolet detection for simultaneous analysis of three sartans (Valsartan, Irbesartan and Telmisartan) has been developed for quality control. Indian Journal of Pharmaceutical Education and Research. 2017; 51(2): 343-348.
5. Thula KC. Development and validation of first-order derivative UV spectrophotometric method for simultaneous estimation of Nebivolol and Clinidipine in a pharmaceutical. International Journal of Pharmaceutical Science. 2015; 31(1): 243-247.et
6. Mittal A. Design of experiment based optimized RP-HPLC Method for simultaneous estimation of Amlodipine and Valsartan in bulk and tablet formulations. Austin Journal of Analytical and Pharmaceutical Chemistry. 2015; 2(6): 1057.
7. Bhavani LRD and Durgaaruna R. Method development and validation of HPLC for determination of Levetiracetam and Valsartan in their formulations. Research and Reviews Journal of Pharmaceutical Analysis. 2015; 4(2): 42-56.
8. Heli RV, Patel SS, Ladva BJ, Nayak BS, Patel SJ and Mahida VM. Development of Stability indicating HPLC Method for simultaneous estimation of Nebivolol hydrochloride and Valsartan in the tablet dosage form. World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(6): 662-670.
9. Kumari B and Garg R. Drug profile of Valsartan: A review. World Journal of Pharmaceutical Sciences. 2015; 3 (8): 1598-1606.
10. Shirkhedkar AA. A concise review of the analytical profile of Valsartan. Eurasian Journal of Analytical Chemistry. 2017; 12 (4): 337-364.
11. Ola MA. HPLC- fluorescence determination of Valsartan in human volunteers and its application in bioequivalence study of two Valsartan tablets. Life Science Journal. 2013; 10(2): 583-590.
12. Madhavi C, Siddartha B and Parthiban C. Simultaneous estimation and validation of Nebivolol and Valsartan in tablet dosage form by RP-HPLC. International Journal of Pharmacy and Pharmaceutical Sci. 2014; 6(1): 278-281.
13. Sastry BS, Srinivasulu D and Ramana H. Reverse Phase HPLC Method for the analysis of Nebivolol in pharmaceutical dosage forms. JPRHC. 2009; 1(1): 25-33.
14. Haque MA, Hasan SA, Kumar PK, Nivedita G, Kumar PT, Dibyalochan M and Diwan P. Stability indicating RP-HPLC method for the estimation of Valsartan in the pharmaceutical dosage form. IOSR Journal of Pharmacy. 2012; 2(4): 12-18
15. Patel NR and Patel SK. First derivative spectrophotometric method for the simultaneous estimation of Valsartan and Hydrochlorothiazide in their combined dosage form. International Journal of Pharmacy and Life Sciences. 2012; 3(7): 1828-1832
16. Jothieswari D, Priya D, Brito R, Mohanambal SE and Wasim RS. Design and RP-HPLC method for the simultaneous determination of Valsartan and Hydrochlorothiazide in Bulk and in the pharmaceutical. International Journal of Novel Trends in Pharmaceutical Sciences. 2011; 1(1): 18-22
17. Kumbhar ST. A validated HPTLC method for simultaneous quantification of Nebivolol and Hydrochlorothiazide in bulk and tablet formulation. International Journal of Pharmaceutical Sciences and Drug Research. 2011; 3(1): 62-66.
18. Modiya JS. 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.
19. Chaudhary AB. Estimation of Valsartan and Hydrochloro-thiazide in pharmaceutical dosage forms by absorption ratio method. International Journal of Applied Biology and Pharmaceutical Technology. 2010; 1(2): 455-465.
20. Sharma A, Patel B and Patel R. Simultaneous Estimation of Nebivolol Hydrochloride and Amlodipine besylate by High-Performance Thin Layer Chromatography. International Journal of Pharma and Bio Sciences. 2010; 1(4): 339-347.
21. Paithankar HV. HPLC method validation for pharmaceuticals: A Review. International Journal of Universal Pharmacy and Bio Sciences. 2013; 2(4): 229-240.
22. ICH, Q2A, Text on validation of analytical Procedures International Conference on harmonization, Geneva. 1994:1-5.
23. ICH, Q2B, Validation of analytical Procedure: Methodology, International conference on Harmonization, Geneva. 1996: 1-8.
24. ICH, Q2R1, Text on validation of analytical Procedures International Conference on harmonization, Geneva. 1994: 1-13.