Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40µg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.
Cite this article:
Priya, Archana Gahtori. UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):94-8. doi: 10.52711/2231-5675.2022.00017
Priya, Archana Gahtori. UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):94-8. doi: 10.52711/2231-5675.2022.00017 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-2-5
2. Chitlange SS, Bagri K, Sakarkar DM. Stability Indicating RP- HPLC Method for Simultaneous Estimation of Valsartan and Amlodipine in Capsule Formulation. Asian J. Research Chem. 1(1): July-Sept. 2008; Page 15-18.
3. Patil PR, Rakesh SU, Dhabale PN, Burade KB. Simultaneous UV Spectrophotometric Method for Estimation of Losartan Potssium and Amlodipine Besylate in Tablet Dosage Form. Asian J. Research Chem. 2(2): April-June, 2009 page 183-187
4. Mehulkumar P, Ramesh V, Vinay kumar V, Srinivas R, Diwan PV. Simultaneous Spectroscopic Estimation of Amlodipine Besylate and Olmesartan Medoximil in Tablet Dosage Form. Asian J Research Chem. 2(2): April-June, 2009; Page127-130
5. Salve P, Gharge D, Kirtawade R, Dhabale P, Burade K. Simple Validated Spectroscopic Method for Estimation of Amlodipine Besylate from Tablet Formulation. Asian J. Research Chem. 2(4): Oct.-Dec. 2009 page 553-555.
6. Bhatia NM, Deshmane SJ, More HN, Choudhari PB. Simultaneous Spectrophotometric Estimation of the Amlodipine Besylate and Hydrochlorothiazide in Pharmaceutical Preparations and Biological Samples. Asian J. Research Chem. 2(4): Oct.-Dec. 2009 page 393-397
7. Golher HK, Pillai S. Simultaneous Estimation of Amlodipine Besylate and Telmisartan by UV- Spectrophotometry. Research J. Pharm. and Tech.3 (4): Oct.-Dec.2010; Page 1218-1221.
8. Nayak SP, Pillai S. Simultaneous Estimation of Amlodipine besylate and Perinopril erbumine by UV Spectrophotometric Method. Research J. Pharm. and Tech. 4(5): May 2011; Page 735-738.
9. Kakde RB, Kotak VH, Barsagade AG, Chaudhary NK, Kale DL. Spectrophotometric Method for Simultaneous Estimation of Amlodipine Besylate and Bisoprolol Fumarate in Pharmaceutical Preparations. Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008; Page 513-515.
10. Patil PR, Rakesh SU, Dhabale PN, Burade KB. Simultaneous Estimation of Ramipril and Amlodipine by UV Spectrophotometric Method. Research J. Pharm. and Tech. 2 (2): April-June.2009, Page 304-307.
11. Masih M, et al. Spectrophotometric simultaneous equation of amlodipine besylate and losartun potassium in tablet dosage forms. Asian Journal of Pharmaceutical and Clinical Research. 2014 vol. 7, issue 4,
12. Mathew BM, Senthilkumar KL. spectrophotometric method of estimation of amlodipine besylate using hydrotropic solubilization. Journal of Applied Pharmaceutical Sciences. 2011; 01(09):177-180
13. Baghel US, Singhal M, Gupta MM, et al. Analytical method validation for tablet of phenoxymethyl penicillin potassium by HPLC method. Journal of Chemical and Pharmaceutical Research. 2009; 1(1): 271-275.
14. Gidwani B, Vyas A. UV-spectrophotometric method for estimation of altretamine in bulk and pharmaceutical solid dosage form. J. Atoms and molecules. 2015; 5(1)l: 860-871.
15. Kumar JP, Rajesh BH, Raveendra GB. Visible spectroscopic method for estimation of Amlodipine besylate in tablets. International Journal of Pharmaceutical, Chemical and Biological Sciences. 2014; 4(1): 173-177.
16. Gohil K, Trivedi P, Molvi KI. Spectrophotometric analysis of amlodipine besylate in bulk and in tablet dosage forms. Indian Journal Pharma Sci. 2005; 67:376-378.
17. Prabhakar AH, Giridhar R. Spectrophotometric method for determination of amlodipine besylate in pure form and in tablet. Indian Drugs. 2003; 39:204-208.
18. Wankhede SB, Wadkar SB, Raka KC, et al. Simultaneous Estimation of Amlodipine Besilate and Olmesartan Medoxomil in Pharmaceutical Dosage Form. Indian J Pharm Sci. 2009; 71(5): 563–567.
19. Gupta KR, Mahapatra AD, Wadodkar AR et al. Simultaneous UV Spectrophotometric Determination of Valsartan and Amlodipine in tablet International Journal of Chem Tech Research. 2010; 2(1): 551-556
20. Bhatia NM, Deshmane SJ, More HN, Choudhari PB. Validated RP-HPLC Method for Simultaneous Determination of Amlodipine Besylate and Hydrochlorothiazide from Pharmaceutical Preparation and Biological Samples. Research J. Pharm. and Tech. 2 (3): July-Sept. 2009, Page 482-486.