Volume : 13, Issue : 09, September – 2026
Title:
ANALYTICAL METHOD DEVELOPMENT FOR THE DETERMINATION OF R-PHENETHYLAMINE ASSAY BY HPLC
Authors :
Basavarajula Shivacharan*, Dr. K. Hariprasad
Abstract :
A novel, specific, accurate, rugged, precise reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Phenethylamine by using Symmetry Xterra C18 (4.6mm x 150mm, 5m) column with a mobile phase containing a mixture of Acetonitrile and Potassium dihydrogen phosphate buffer adjusted to pH-2.8 with ortho phosphoric acid in the ratio of 35:65. The flow rate was 1.0 ml/min and effluent was monitored at 246 nm and a peak eluted at 4.865 min and column oven temperature was maintained ambient. Calibration curve was plotted with a range from 10- 30 µg/ml. The LOD and LOQ values of Phenethylamine were found to be 1.3µg/ml and 3.9µg/ml respectively. The percentage recovery of the Phenethylamine was found to be within the limits. The developed RP-HPLC method was validated according to the current International Conference on Harmonization (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision and robustness. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Phenethylamine in bulk drug and in its pharmaceutical dosage form. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.
Keywords: Phenethylamine, RP-HPLC, Accuracy, Validation, ICH Guidelines.
Cite This Article:
Please cite this article in press Basavarajula Shivacharan et al., Analytical Method Development For The Determination Of R-Phenethylamine Assay By Hplc.,. Indo Am. J. P. Sci, 2026; 13(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. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
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. New York: 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 B K, Instrumental method of chemical analysis Meerut. (1999), PP 175-203.
8. Breaux J and Jones K: Understanding and implementing efficient analytical method development and validation. Journal of Pharmaceutical Technology (2003), 5, PP 110-114.
9. Willard, H. y. Merritt L.L, Dean J.A and Settle F.A “Instrumental methods of analysis” 7th edition CBS publisher and distributors, New Delhi, (1991), PP 436-439.
10. ICH Q2A, “validation of analytical methods, definitions and terminology”, ICH Harmonized tripartite guideline, (1999).
11. Sharma BK. Instrumental Method of Chemical Analysis. 20th Ed. Meerut: Goel Publishing House; 2001: 54-83.
12. Ashutoshkar. Pharmaceutical Drug Analysis. 2nd Ed. New Delhi: New Age International Publisher; 2005: 455-466.
13. Ahuja S, Michael WD. Hand book of Pharmaceutical Analysis by HPLC. 1st Ed.London: Elsevier Academic Press; 2005: 44-54.
14. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC Method Development. 3rd Ed. New York: Wiley; 1988: 227.
15. Skoog DA, West DM. Principles of Instrumental Analysis. 2nd Ed. Saunders Golden Sunburst Series. Philadelphia; 1980: 674-675, 690-696.
16. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), PP 1-7.
17. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
18. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
19. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
20. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
21. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
22. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
23. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
24. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC.
25. https://www.drugbank.ca/drugs/DB04325
26. https://pubchem.ncbi.nlm.nih.gov/compound/Phenethylamine
27. https://en.wikipedia.org/wiki/Phenethylamine
28. https://www.webmd.com/vitamins/ai/ingredientmono-1274/phenethylamine
29. A.P. Suthar1 *, S.A. Dubey1 and S.R. Patel2, A Validated Specific Reverse Phase Liquid Chromatographic Method for the estimation of Sibutramine Hydrochloride Monohydrate in bulk drug and capsule dosage forms, International Journal of ChemTech Research, Vol.1, No.4, pp 793-801, Oct-Dec 2009.
30. G. A. Shabir, Development and Validation of R