Author(s):
Rakam Gopi Krishna, M. Srinivasa Murthy, V. Kavya
Email(s):
gopirakam@gmail.com
DOI:
10.52711/0974-360X.2021.01019
Address:
Rakam Gopi Krishna1*, M. Srinivasa Murthy1, V. Kavya2
1Department of Pharmaceutical Analysis, Vignan Institute of Pharmaceutical Sciences, Deshmukhi, Pochampally, Hyderabad. Telangana 508284 India.
2Department of Pharmaceutical Analysis, Chaitanya College of Pharmacy Education & Research, Hanamkonda, Warangal, Telangana 506001 India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 11,
Year - 2021
ABSTRACT:
The objective of the study was to develop RP-HPLC method for the determination of purity of sumatriptan in bulk and pharmaceutical dosage form. The development of an analytical method for the determination of drugs by HPLC has received considerable attention in recent years because of their importance in quality control of drugs and drug products. The aim of this current study was to develop a simple, rapid, precise, accurate and sensitive HPLC method for the analysis of sumatriptan in bulk and its pharmaceutical dosage form by using solvent system of TEA : ACN : methanol in the ratio 80:10:10 and C8 ODS Inertsil (250*4.6mm, 5?i.d) stationary phase. The chromatographic condition is set at flow rate of 1ml/min with PDA detector at 221 nm. As per ICH requirements validation studies are carried out by using freshly prepared solutions. The linearity was demonstrated over the concentration range of 5-150 µg / ml and value was found to be as 0.99998. The %RSD of precision was found to be 0.260. The LOD and LOQ were found to be 1.967µg/ml and 5.961µg/ml respectively. Forced degradation studies were carried out under various stress conditions to demonstrate the stability-indicating capability of the developed RP-HPLC method. The proposed method was found to be simple, precise, accurate and validated according to the International Council for Harmonisation guidelines.
Cite this article:
Rakam Gopi Krishna, M. Srinivasa Murthy, V. Kavya. Method development and validation of RP-HPLC method for the determination of sumatriptan in bulk and pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2021; 14(11):5856-2. doi: 10.52711/0974-360X.2021.01019
Cite(Electronic):
Rakam Gopi Krishna, M. Srinivasa Murthy, V. Kavya. Method development and validation of RP-HPLC method for the determination of sumatriptan in bulk and pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2021; 14(11):5856-2. doi: 10.52711/0974-360X.2021.01019 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-11-44
REFERENCES:
1. Kamboj PC. Pharmaceutical analysis. Vallabh Publications. New Delhi. 2nd Edn. 2007.
2. Erwing GW. Instrumental Methods of Chemical Analysis. Mc Graw Hill Boo Company, Inc., 2nd Edn, 1960.
3. Lavanya G, Sunil M, Eswarudu MM, Chinna Eswaraiah M, Harisudha K, Spandana B. Analytical method validation: An updated review. International Journal of Pharmaceutical Science and Research. 2013; 4(4): 1280-1286.
4. Ambadas R and Prasanna A. Development and validation of HPTLC method for simultaneous estimation of gatifloxacin and ornidazole in human plasma. Journal of Chromatography Separation Techniques. 2011; (2): 115.
5. Connors KA. A text book of Pharmaceutical Analysis. John Wiley and Sons. 3rd edition, 1999.
6. Connors, K.A. A text book of pharmaceutical analysis. John Wiley and Sons. 3rd edition. 2002.
7. Rajesh Kumar N, Sunil Kumar S, Susanta Kumar P. Method development and validation of Sumatriptan in bulk and pharmaceutical dosage forms by UV spectrophotometric method. International Journal of Pharmaceutical and Biological Archives. 2011; (2): 1100-1105.
8. Kalyanaramu B, Raghubabu K. A simple visible spectrophotometric determination of Sumatriptan Succinate from pharmaceutical formulations. Der Pharma Chemical, 2011; (3): 223-228.
9. Sunil Reddy P, Veera Raghava Raju T, Satyanarayana Raju P, Sunil Varma N, Sudhakar Babu K. Development and validation of a stability-indicating RP-UPLC method for the estimation of impurities in cinacalcet hydrochloride API and its formulation. Scientia Pharmaceutica. 2015; 83: 583-598.
10. Seshukumar D, Abhishek G, Srinivas KS, Ravi Shankar G and Vinod Prasad S. Development and validation of stability indicating RP-UPLC method for simultaneous determination in fixed dose combination of ezetimibe and simvastatin. Journal of Chromatography Separation Techniques. 2012; (3): 131.
11. Choy Fun Wong, Kah Hey Yuen, Kok Khiang Peh. Formulation and Evaluation of controlled release Eudragit buccal patches. International Journal of Pharmaceutics. 1999; 178:11-22.
12. Ge Z, Tessier E, Neirinck L and Zhu Z. HPLC method for the determination of sumatriptan with fluorescence detection in human plasma. J Chromatogr B Analyt Technol Biomed Life Sciences. 2004; 806: 299-303.
13. Majithiya R.J, Majithiya J.B, Umrethia M.I and Murthy Y. HPLC method for the determination of sumatriptan in plasma and brain tissue. Ars Pharmaceutica. 2006; (47): 199-210.
14. Ravi S, Dawis Y and Khan N. Development and validation of an RP-HPLC-UV method for analysis of sumatriptan in dosage forms. Acta Chromatographica. 2009; (21): (3): 421-432.
15. Shirisat V.A, Gabhe S.Y and Deshpande S.G. HPLC Determination of Sumatriptan from pharmaceutical preparations. Indian Drugs. 1998; 35 (7): 404-407.
16. Sukhadev Singh and Jain R. HPLC method for the determination of sumatriptan. Indian Drugs. vol.34 (9); 1997: 527-531.
17. Badwe N, Sharma N, Agarwal N. HPLC method for the determination of sumatriptan. Eastern Pharmacist. 1997; (475): 121-122.
18. Lokesh Singh, Sanju Nanda, Rajiv Chomwal. A validated sensitive LC method for the estimation of sumatriptan succinate in bulk and tablet dosage form. Chronicles of Young Scientists. 2011; 2 (1): 37-41.
19. Boulton D.W, Duncan G.F and Vachharajani N.N. Validation and application of HPLC/ tandem mass spectrometry assay for sumatriptan in human plasma. Biomed. Chromatography B. 2003; 17: (1); 48-52.
20. McLoughlin D.A, Olah T.V, Ellis J.D and Gilbert J.D. Quantization of the 5HT1D agonist and sumatriptan in plasma by LC atmos. pressure chemical ionization mass spectrometry. J Chromatograph A. 1996; 726: 115-124.
21. Cheng K.N, Redrup M.J, Barrow A and Williams P.N. Validation of LC tandem mass spectrophotometric method for determination of Sumatriptan in human biological fluids. J Pharm. Biomed Anal. 1998; 17(3): 399-408.
22. Oxford J and Lant M. LC-MS method for the determination of sumatriptan. J Chromatograph. 1989; 496(1): 137-140.
23. Dunne M and Andrew P. Fully automated assay for the determination of Sumatriptan in human serum using solid phase extraction and HPLC with electrochemical detection. J Pharm. Biomedical Anal. 1996; (14): 721-726.
24. Andrew P.D, Birch H.L and Phillpot D.A. The determination of sumatriptan in plasma and urine by HPLC with electrochemical detection. J Pharm. Sci. 1993;82: 73-76.
25. Franklin M, Odontiadis J and Clement E.M. The determination of Sumatriptan in human plasma by HPLC with coulometric detection and utilization of solid phase extraction. J Chromatography B Biomed Sci. Appl. 1996; 681: 416-420.
26. Moneti G. Analysis of sumatriptan in cerebro Spinal fluid using capillary LC/MS/MS. In; from: http:/wwwl.dionex.com/enus/literature/lp56178.html.
27. Shah C.R, Suhagia B.N, Shah N.J and Shah R.R. Development and validation of a HPTLC method for estimation of sumatriptan in dosage forms. Indian J Pharm. Sci.2008; 70(6): 831-834.
28. Tipre D.N and vavia P.R. Estimation of sumatriptan by spectrometric and HPTLC method. Indian Drugs. 1999; 36 (8): 501-505.
29. Avadhanulu A.B, SrinivasJ.S and Anjaneyulu Y. RP-HPLC and Colorimetric method for the determination of sumatriptan in its drug form. Indian Drugs. 1996; 33(7): 334-337.
30. Prabakar A.E, Kalaichelvi R, Thangabalan B, Karthikeyan R, Ch. Prabakar and Vijay kumar. Validated spectroscopic method for estimation of sumatriptan succinate in pure and from tablet formulations. Research J Pharm. and Tech. 2009; 2(3): 495.
31. Sagar K, Alvarez J.M.F, Hua C, Smyth S.R and Munden R. The determination of sumatriptan by Voltametry. J Pharm. Biomed Anal. 1992; 10(1): 17-21.
32. Altria K.D and Filbey S.D. Determination of sumatriptan by capillary electrophoresis. Anal Proc. 1993; (30): 363.
33. Bebawy L.I, Moustafa A.A and Abo-Talib N.F. Densitometry and spectrophotometric detection of sumatriptan. J Pharm. Biomed Anal. 2003; (32): 1123.
34. ICH- Harmonised Tripartity Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1). IFPMA: Geneva, 2005.