Volume : 11, Issue : 10, October – 2024
Title:
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND ASPIRIN IN BULK COMBINED TABLET DOSAGE FORM
Authors :
K.Sravanthi*, K.Usha, Ch.Sunitha
Abstract :
A New RP-HPLC Method for the Simultaneous Estimation of Atorvastatin and Aspirin in bulk and its Pure and Pharmaceutical Dosage Form as per ICH Guidelines. The Present work was to develop a simple, fast, accurate, precise, reproducible,Reverse Phase High Performance Liquid Chromatographic Method forsimultaneous estimation of Atorvastatin and Aspirinin pure and combined dosage form. Chromatographic separation was done usingSymmetry ODS C18 column having dimension of 4.6×250mm having particle size of 5.0µm, with mobile phase consisting of Acetonitrile: Methanol in the ratio 65:45v/v, flow rate was adjusted to 1ml/min and detection wavelength at 256nm. The retention times of Atorvastatin and Aspirinwas found to be 2.256 and 5.427 mins. The proposed method has been validated foraccuracy, precision, linearity; robustness and range were within the acceptancelimit according to ICH guidelines. Linearity for Atorvastatin and Aspirinwas found in range of 6µg-14µg and 18µg-42µg and correlation coefficient was foundto be 0.999 and 0.999% RSD for intermediate precision was found to be 0.5 and 0.3, for repeatability was 0.4 and 0.1, % mean recovery for Atorvastatin and Aspirin was found to be 101.326% and 100.501% respectively. The method wasfound to be robust even by change in the mobile phase ±2% and in more and less flowconditions. The developed method can be successfully employed for the routineanalysis of Atorvastatin and Aspirinin bulk and Pharmaceutical dosageforms.
Keywords:Atorvastatin and Aspirin, RP-HPLC, Validation, Accuracy.
Cite This Article:
Please cite this article in press K.Sravanthi et al Development And Validation Of RP-HPLC Method For The Simultaneous Estimation Of Atorvastatin And Aspirin In Bulk Combined Tablet Dosage Form..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
References:
1. Shethi PD. HPLC- Quantitative analysis of pharmaceutical formulations. 1st Ed. New Delhi: CBS Publishers & Distributors; 2001: 8-10, 101-103.
2. Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pharmaceutical Analysis: Vol-II. 8th Ed. Pune: Nirali Prakashan; 2002: 48-57.
3. Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC. M.Pharm Thesis, Maliba Pharmacy College, Gujarat Technological University, Gujarat, India, 2011: 7-28.
4. Gabor S. HPLC in pharmaceutical Analysis: Vol. I. 1st Ed. London: CRC Press; 1990:101-173.
5. Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th Ed. NewYork : John Wiley & Sons Inc; 1991: 217-235.
6. Hobart HW, Merritt LL, John AD. Instrumental Methods of Analysis. 7th Ed. New Delhi: CBS Publishers; 1988: 580-610.
7. Sharma BK. Instrumental Method of Chemical Analysis. 20th Ed. Meerut: Goel Publishing House; 2001: 54-83.
8. Ashutoshkar. Pharmaceutical Drug Analysis. 2nd Ed. New Delhi: New Age International Publisher; 2005: 455-466.
9. Ahuja S, Michael WD. Hand book of Pharmaceutical Analysis by HPLC. 1st Ed.London: Elsevier Academic Press; 2005: 44-54.
10. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC Method Development. 3rd Ed. New York: Wiley; 1988: 227.
11. Skoog DA, West DM. Principles of Instrumental Analysis. 2nd Ed. Saunders Golden Sunburst Series. Philadelphia; 1980: 674-675, 690-696.
12. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), PP 1-7.
13. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
14. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
15. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.