S. Sangeetha, S. Alexandar, M. V. Kumudhavalli, M. Kumar
S. Sangeetha*, S. Alexandar, M. V. Kumudhavalli, M. Kumar
Department of Pharmaceutical Chemistry, Vinayaka Mission’s College of Pharmacy, Salem - 636008,
Vinayaka Mission’s Research Foundation (Deemed to be University) Tamilnadu, India.
Volume - 16,
Issue - 3,
Year - 2023
An excellent method with simple, precise was developed for Nebivolol HCl and Valsartan by using Forced degradation UPLC method. The column used was C-18 BEH _ 1.7µm x 2.1 x 50mm in ambient temperature. Flow rate was 0.8ml/min, wavelength of 278nm, mobile phase used was acetonitrile : Buffer (50:50). Buffer used 0.01 N Disodium hydrogen phosphate with pH 3.5 adjusted by OPA. Run time 4 min. The percentage purity and RT of Nebivolol HCl and Valsartan was found to be 99.72 and 99.30 and 1.193 and 1.827 respectively. The validation parameters was carried out, linearity of Nebivolol HCl was found to be (1µgm/ml to 8µgm/ml) R2= 0.998 and Valsartan was found to be (16µgm/ml to 128.8µgm/ml) R2= 0.999. Intermediate precision, Robustness, LOD LOQ was within the limit as per ICH guidelines. Recovery studies taken place in 80%, 100% and 120. Forced Degradation was carried out in three conditions acidic, basic and peroxide condition, degradation takes at basic and peroxide. As per literature review there is no method developed for Nebivolol HCl and Valsartan in Forced degradation UPLC method. So we made attempt to develop the Nebivolol HCl and Valsartan in UPLC method.
Cite this article:
S. Sangeetha, S. Alexandar, M. V. Kumudhavalli, M. Kumar. Development and Validation of a Forced Degradation UPLC Method for the Simultaneous Determination of Nebivolol HCl and Valsartan in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(3):1002-6. doi: 10.52711/0974-360X.2023.00167
S. Sangeetha, S. Alexandar, M. V. Kumudhavalli, M. Kumar. Development and Validation of a Forced Degradation UPLC Method for the Simultaneous Determination of Nebivolol HCl and Valsartan in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(3):1002-6. doi: 10.52711/0974-360X.2023.00167 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-3-3
1. Kalpana Nekkala V. Shanmukha Kumar J. Ramachandran D. Ganji Ramanaiah. Ganta Srinivas. et al Method Development And Validation Of Stability Indicating RP-HPLC Method For Simultaneous Estimation Of Nebivolol HCL And Valsartan In Bulk And Its Pharmaceutical Formulations. American Journal of Advanced Drug Delivery 2014; 2(5):624-637.
4. Blessy M. Ruchi D. Patel Prajesh N. Prajapati Y. Agrawal K. et al Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis 2014; 4(3):159-165.
5. ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization. Available from: 〈http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf〉
6. Antil P. Kaushik D. Jain G. Srinivas KS. Indu Thakur. UPLC Method for Simultaneous Determination of Valsartan & Hydrochlorothiazide in Drug Products India Chromatography Separation Techniques.
7. Swartz ME. Ultra Performance Liquid Chromatography: Tommorrows HPLC Technology Today. 2004; 6-9. Lab Plus Int publishing.
8. Ramakrishna NV. Vishwottam KN. Koteshwara M. Manoj S.Santosh M. Varma DP. et al 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.
9. Kokil SU. Bhatia MS. Simultaneous Estimation of Nebivolol Hydrochloride and Valsartan Using RP-HPLC. Indian Journal of Pharmaceutical Sciences. 2009; 71(2), 111-114.
10. Arunadevi S. Birajdar. Subramania Nainar Meyyanathan. Bhojraj Suresh. et al 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.
11. Vanita P. Rode, Madhukar R. Tajne A. Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Analysis of Pitavastatin in Bulk Drug and Tablet Fomulation. Asian Journal of Pharmaceutical Analysis, 2018; 8(1), 49-52.
12. Phalguna Y. Noor Jahan. Indraja N. Satheesh Kumar G. et al. Analytical Method Development and Validation for the Estimation of Sacubitril and Valsartan in Combined Pharmaceutical Dosage Forms by RP-HPLC, Asian Journal of Research in Pharmaceutical Sciences. 2018; 8(1),9-16.
13. Chinmaya Keshari Sahoo . Muvvala Sudhakar D. Venkata. R. Satyanarayana K. Kanhu Charan Panda. Validation of Analytical Procedures- A Review. Asian Journal of Pharmaceutical Analysis. 2018; 8(2), 109-116.
14. Tarte PS. Wate SP. Khedikar PB. Satpure BT. Pawnikar G. Simultaneous Estimation of Nebivolol and Hydrochlorothiazide in Combined Tablet Dosage Form by Multicomponent Mode of Analysis, Asian J. Research Chem. 2008; 1(2), 77-79.
15. Sharma M. Sharma A. Jain A. Banerjee PS. Spectrophotometric Estimation of Valsartan in Tablet Dosage Form, Asian J. Research Chem. 2009; 2(4) 74-76.
16. M. Jagadeeswaran, N. Gopal and T. Sivakumar, Simultaneous Estimation and Validation of Amlodipine Besylate and Nebivolol Hydrochloride in Tablet Formulation by RP-HPLC Method, Asian J. Research Chem. 2010,3(3) 640-642.
17. Gandla KS. N. Ravindra, S. Sowmya. A New RP-HPLC Method Development and Validation for the Simultaneous Estimation of Amlodipine and Valsartan in Tablet Dosage Forms. Asian J. Pharm. Ana. 2014, 4(3) 103-107.
18. Farhana V. Buchiya, Ashif I. Bhim, Hasumati A. Raj, Vineet C. Jain. Simultaneous Determination of Cilnidipine and Valsartan in Synthetic Mixture using Spectrophotometric Technique (Simultaneous Equation Method). Asian J. Pharm. Ana. 2015 5(1) 21-25.