Development and Validation of Difference Spectrophotometric Method for Simultaneous Estimation of Rosuvastatin Calcium and Aspirin in Marketed Formulation
DOI:
https://doi.org/10.22270/ajprd.v9i6.1046Keywords:
UV-difference spectrophotometric method, Rosuvastatin calcium, Aspirin, Vierordt's method, Method validation, ICH guidelines.Abstract
Objective: To develop and validate a simple Vierordt method for the simultaneous estimation of rosuvastatin calcium (RSV ca) and aspirin (ASP) in fixed dose combination capsules by difference spectrophotometry technique in the UV region. Difference spectrophotometry is based on the utilization of difference absorption spectra corresponding to the same compound obtained at two different pH values.
Methodology: The difference in spectral characteristics for the two drugs was observed in 0.01N acetic acid and 0.01N NaOH. The simultaneous equations were developed using difference absorbance and absorptivity values of the two drugs measured and calculated at 243.2nm and 297nm for RSV ca and ASP respectively.
Results: Two drugs have shown very good linearity in the concentration range of 10-100µg/ml. The methods were validated as per ICH guidelines for the limit of detection, the limit of quantification, accuracy, and precision, which were found to be within the acceptable limits. The validated method was successfully applied for the analysis of rosuvastatin calcium and aspirin in fixed dose combination capsules.
Conclusion: Because this approach is simple and does not require a particular programme, it can be used as a substitute for LC methods in quality control laboratories that lack the necessary equipment for those techniques.
Downloads
References
2. Pharmacopoeia I. Indian Pharmacopoeia Commission, Ghaziabad, Published by Government of
3. India, Rosuvastatin calcium, III. 2072-2073. Aspirin, II. 2010:842-3
4. Singh RD, Yadav H, Hinge M, Patel A. Development and validation of analytical methods for
5. simultaneous estimation of rosuvastatin, clopidogrel, and aspirin in a pharmaceutical dosage form. J
6. Pharm Sci. 2016
7. Eligros Kujur, Madhu Sahu, Neha Dubey, Ajit Pandey, Chanchaldeep Kaur. Validated analytical
8. method development for rosuvastatin calcium by difference spectroscopy. International journal of
9. pharmacy and pharmaceutical research. May 2018; vol.12: issue 2
10. 5. Attimarad M, Alkadham A, Almosawi MH, Venugopala KN. Development of rapid and validated
11. RP-HPLC method for Concurrent quantification of rosuvastatin and aspirin Form solid dosag form.
12. Indian J. Pharm. Educ. Res. 2018 Jan 1;52:151-8
13. 6. Savale S, Mahajan H. UV spectrophotometric method development and validation for quantitative
14. estimation of diclofenac sodium. Asian Journal of Biomaterial Research. 2017;3(2):40-3
15. 7. Kumaraswamy G, Lalitha R, Vijayaprakash K. Validated spectrophotometric method for
16. simultaneous estimation of rosuvastatin calcium and aspirin in tablet dosage forms. International
17. Journal of Pharmaceutical Chemistry and Analysis. 2016;3(2):90-8.
18. 8. Kapugandi AN, Gandhi BM, Raju VB. Development and Validation of Stability Indicating RP
19. HPLC Method for Simultaneous Estimation of Ramipril, Aspirin, and Simvastatin in Bulk and
20. Pharmaceutical Dosage Form. Asian J. Biomed and pharm sci. 2016;6(53):14-20
21. 9. Panchal A, Sanghvi G, Vachhani A, Sheth N, Vaishnav D. Simultaneous determination of Aspirin
22. and Rosuvastatin Calcium in capsules by using RP-HPLC coupled with photodiode array detection.
23. International Letters of Chemistry, Physics, and Astronomy. 2014;14:218-30.
24. 10. Purkar AJ, Balap AR, Sathiyanarayanan L, Mahadik KR. Development and validation of HPTLC
25. method for simultaneous determination of Rosuvastatin calcium and aspirin in its pure and
26. pharmaceutical dosage form. Int J Pharm Pharm Sci. 2014;6(5):704-6.
27. 11. Reddy SA, Sekhar KC. Development of a UV spectrophotometric method for the simultaneous
28. estimation of rosuvastatin calcium and aspirin in tablets. Journal of global trends in pharmaceutical
29. sciences. 2012; 3(4): 870-875.
30. 12. Ambole SR, Shirote PJ, Kondawar MS. Simultaneous Estimation for Rosuvastatin calcium and
31. Aspirin from Capsule Dosage Forms by First Order. Derivative Spectroscopic Method.
32. International Journal of ChemTech Research. 2012;4(3):966-70.
33. 13. Patel MJ, Panchal HJ. Simultaneous estimation of aspirin and rosuvastatin calcium in combined
34. dosage form using derivative spectrophotometric method. Int J Pharm Professional’s Res.
35. 2012;3(1):540-5.
36. 14. Godavariya VD, Prajapati PB, Bodiwala KB, Shah SA. Development and validation of two
37. spectrophotometric methods for the simultaneous estimation of rosuvastatin calcium and aspirin in
38. their combined dosage form. Asian Journal of Research in Chemistry. 2012;5(2):275-8.
39. 15. Purkar AJ, Balap AR, Jadhav SB, Chaudhari PD. Development and validation of UV
40. spectrophotometric method for simultaneous determination of rosuvastatin calcium and aspirin in
41. its pure and pharmaceutical dosage forms. Int J Pharm Chem Sci. 2012;1(3):1008-12.
42. 16. Bhattacharya I, Bhattacharya SP, Talukdar S, Medya S. Development of difference
43. spectrophotometric method for the estimation of aspirin in formulation using hydrotropy. Int. J.
44. Res. Pharm. Sci. 2011; 2(1): 84-7.
45. 17. Uyar B, Celebier M, Altinoz S. Spectrophotometric determination of rosuvastatin calcium in
46. tablets. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2007 Jun
47. 1;62(6):411-3.
48. 18. Skoog DA, Holler FJ. TA Nieman Principles of instrumental analysis 5th ed. Saunders College
49. Publ., Philadelphia. 1998.
50. 19. Beckett AH, and Stenlake JB. Practical pharmaceutical chemistry. 4th edition, part 2. CBS
51. publishers and distributors. 1997; pp 284-286,293-296.
52. 20. Sethi PD. Quantitative analysis of drugs in pharmaceutical formulations, 3rd ed. CBS publications,
53. New Delhi; 2008: 573-75.
54. 21. Guideline ICH. Validation of analytical procedures: text and methodology. Q2 (R1). 2005
55. Nov;1(20):05.
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.