Main Article Content
Abstract
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the Quantitative Determination of Vildagliptin in active pharmaceutical ingredient and Marketed Pharmaceutical Dosage form.
Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Vildagliptin. The chromatographic strategy utilized Symmetry C18, 250 mm x 4.6 mm i.d.5µm particle size, using isocratic elution with a mobile phase consists of Methanol and Phosphate Buffer (0.02M) (pH-3.8) was taken in the ratio of 70: 30% v/v. A flow rate of 1.0 ml/min and a detector wavelength of 245nm utilizing the UV detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.
Results: LOD and LOQ for the active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.
Keywords
Article Details
References
- 1. Available from: https://go.drugbank.com/drugs/DB04876.
- 2. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Galvus.
- 3. Available from: https://en.wikipedia.org/wiki/Vildagliptin . Wikipedia.
- 4. Snyder R, Kirkland J, Glajch L. Practical HPLC method development. 2nd ed. john Wiley & sons International publication; 2011.
- 5. Ashutoshkar S. Pharmaceutical drug analysis. 2nd ed. New Age International Private Limited Publishers; 2005. p. 452-74.
- 6. Beckett H, Stenlake JB. Practical Pharmaceutical Chemistry, 4th End. C.B.S. Publishers and distributors’. New Delhi. p. 1-9, 157-67.
- 7. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental methods of analysis. 6th ed. CBS Publishers and New Delhi: Distributors. p. 430-40, 495-504, 529-45.
- 8. Sharma BK. Instrumental methods of chemical analysis. Meerut: GOEL Publishing House. p. 286-300.
- 9. Instant notes on analytical chemistry by D. Kealey and P.J. Haines, UK. Vols. 6-7; 2002.
- 10. Chatwal GR, Anand SK. Instrumental methods of Chemical Analysis. 5th ed. Mumbai: Himalaya Publishing House, P-2.566; 2005.
- 11. Swartz ME. J Liq Chromatogr. 2005;28(7/8):1253-63.
- 12. McCulloch M, Zhou X, Xu Y, Brunell S, Spear L. J Chromatogr B Analyt Technol Biomed Life Sci. Published on Jan 18 2008. 2008 March 1;863(2):258-65. doi: 10.1016/j.jchromb.2008.01.020, PMID 18258497.
- 13. International Conference on Harmonization, Harmonized Tripartite Guideline. Validation of analytical procedures. Text and methodology. Q2 (R1); November 2005.
- 14. International Conference on Harmonization (ICH). Validation of analytical methods: definitions and terminology. ICH Q2A; 1994.
- 15. Chem. News & features,. a practical guide to analytical method validation, anal. Green: JM; May 1 1996. p. 305a-9a.
- 16. PA. Winslow and r. F. Meyer, defining a master plan for the validation of analytical methods, j. Validation Technol. 1997:361-7.
- 17. Aoac peer-verified methods program, manual on policies and procedures. Arlington, VA; 1998.
- 18. Patil R. J of chromatographia. 2008;67:575-82.
- 19. Baht and Leena. J Liq Chromatogr. 2007;30:309.
- 20. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental methods of analysis. 7th ed. New Delhi: CBS Publishers; 2002.
- 21. Menon GN, White LB, Department of Analytical Research, Abbott Laboratories, (pub med-index for MEDLINE).
- 22. Food and Drug Administration (FDA). Analytical procedures and methods validation: chemistry, manufacturing and controls documentation. Fed Regist (Notices). 2000;65(169):52776-7.
- 23. Vibha G et al. Development and validation of HPLC method – a review. Int Res J Pharm Appl Sci. 2012;2(4):22-3.
- 24. Bliesner DM. Validating chromatographic methods. John Wiley & sons Inc; 2006. p. 88-92.
- 25. Validation of analytical procedures: methodology. ICH-guidelines Q2B. Geneva. 1996, 11. (CPMP/ICH/281/95).
- 26. Gupta V et al. Development and validation of HPLC method – a review. Int Res J Pharm Appl Sci. 2012;2(4):17-25.
- 27. A review: HPLC method development and validation. Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
- 28. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC chromacademy.
- 29. Sonawane LV. Bioanalytical method validation and its pharmaceutical application- A review pharmaceutica analytical. Acta. 2014;5:3Center for Drug Evaluation and Research (CDER) Reviewer Guidance.
- 30. ICH, Topic Q. 2 (R1) validation of analytical procedures: text and methodology.
- 31. Aparajita Malakar, Bokshi B, Nasrin D. Development and validation of RP-HPLC method for estimation of vildagliptin from tablet dosage form. Int J Pharm Life Sci. August 2012;1(1), Serial 2:1-8.
- 32. Raosaheb JR, Dabhade M. Kokate Shekhar Vikram1, Shinde Vikas Sanjay1 and Shaikh Wasim Chand1, RP-HPLC Method Development and Validation of Vildagliptin in Bulk and Dosage Form. World J Pharm Pharm Sci;6(9):1161-76 P.2.
- 33. Satpathy PR, Goud VM, Bhoga Bhagya JVC. Sharma1 & N. Shyamala, development and validation of a RP-HPLC method for the assay of vildagliptin. World J Pharm Pharm Sci;3(2):2303-10.
- 34. Chaphekar MM, Hamrapurkar PD. Development and validation of RP-HPLC assay method for vildagliptin using Qbd approach and its application to forced degradation studies. Int J Pharm Sci Drug Res. 2016;8(3):157-65.
References
1. Available from: https://go.drugbank.com/drugs/DB04876.
2. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Galvus.
3. Available from: https://en.wikipedia.org/wiki/Vildagliptin . Wikipedia.
4. Snyder R, Kirkland J, Glajch L. Practical HPLC method development. 2nd ed. john Wiley & sons International publication; 2011.
5. Ashutoshkar S. Pharmaceutical drug analysis. 2nd ed. New Age International Private Limited Publishers; 2005. p. 452-74.
6. Beckett H, Stenlake JB. Practical Pharmaceutical Chemistry, 4th End. C.B.S. Publishers and distributors’. New Delhi. p. 1-9, 157-67.
7. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental methods of analysis. 6th ed. CBS Publishers and New Delhi: Distributors. p. 430-40, 495-504, 529-45.
8. Sharma BK. Instrumental methods of chemical analysis. Meerut: GOEL Publishing House. p. 286-300.
9. Instant notes on analytical chemistry by D. Kealey and P.J. Haines, UK. Vols. 6-7; 2002.
10. Chatwal GR, Anand SK. Instrumental methods of Chemical Analysis. 5th ed. Mumbai: Himalaya Publishing House, P-2.566; 2005.
11. Swartz ME. J Liq Chromatogr. 2005;28(7/8):1253-63.
12. McCulloch M, Zhou X, Xu Y, Brunell S, Spear L. J Chromatogr B Analyt Technol Biomed Life Sci. Published on Jan 18 2008. 2008 March 1;863(2):258-65. doi: 10.1016/j.jchromb.2008.01.020, PMID 18258497.
13. International Conference on Harmonization, Harmonized Tripartite Guideline. Validation of analytical procedures. Text and methodology. Q2 (R1); November 2005.
14. International Conference on Harmonization (ICH). Validation of analytical methods: definitions and terminology. ICH Q2A; 1994.
15. Chem. News & features,. a practical guide to analytical method validation, anal. Green: JM; May 1 1996. p. 305a-9a.
16. PA. Winslow and r. F. Meyer, defining a master plan for the validation of analytical methods, j. Validation Technol. 1997:361-7.
17. Aoac peer-verified methods program, manual on policies and procedures. Arlington, VA; 1998.
18. Patil R. J of chromatographia. 2008;67:575-82.
19. Baht and Leena. J Liq Chromatogr. 2007;30:309.
20. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental methods of analysis. 7th ed. New Delhi: CBS Publishers; 2002.
21. Menon GN, White LB, Department of Analytical Research, Abbott Laboratories, (pub med-index for MEDLINE).
22. Food and Drug Administration (FDA). Analytical procedures and methods validation: chemistry, manufacturing and controls documentation. Fed Regist (Notices). 2000;65(169):52776-7.
23. Vibha G et al. Development and validation of HPLC method – a review. Int Res J Pharm Appl Sci. 2012;2(4):22-3.
24. Bliesner DM. Validating chromatographic methods. John Wiley & sons Inc; 2006. p. 88-92.
25. Validation of analytical procedures: methodology. ICH-guidelines Q2B. Geneva. 1996, 11. (CPMP/ICH/281/95).
26. Gupta V et al. Development and validation of HPLC method – a review. Int Res J Pharm Appl Sci. 2012;2(4):17-25.
27. A review: HPLC method development and validation. Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
28. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC chromacademy.
29. Sonawane LV. Bioanalytical method validation and its pharmaceutical application- A review pharmaceutica analytical. Acta. 2014;5:3Center for Drug Evaluation and Research (CDER) Reviewer Guidance.
30. ICH, Topic Q. 2 (R1) validation of analytical procedures: text and methodology.
31. Aparajita Malakar, Bokshi B, Nasrin D. Development and validation of RP-HPLC method for estimation of vildagliptin from tablet dosage form. Int J Pharm Life Sci. August 2012;1(1), Serial 2:1-8.
32. Raosaheb JR, Dabhade M. Kokate Shekhar Vikram1, Shinde Vikas Sanjay1 and Shaikh Wasim Chand1, RP-HPLC Method Development and Validation of Vildagliptin in Bulk and Dosage Form. World J Pharm Pharm Sci;6(9):1161-76 P.2.
33. Satpathy PR, Goud VM, Bhoga Bhagya JVC. Sharma1 & N. Shyamala, development and validation of a RP-HPLC method for the assay of vildagliptin. World J Pharm Pharm Sci;3(2):2303-10.
34. Chaphekar MM, Hamrapurkar PD. Development and validation of RP-HPLC assay method for vildagliptin using Qbd approach and its application to forced degradation studies. Int J Pharm Sci Drug Res. 2016;8(3):157-65.