RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ASPIRIN, RAMIPRIL, HYDROCHLOROTHIAZIDE, SIMVASTATIN AND ATENOLOL FROM PHARMACEUTICAL DOSAGE FORM
Objective: The present study was designed with an objective of a simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol from bulk drug and formulation.
Methods: The separation was achieved on a Hypersil Gold column (250 mm X 4.6 mm, 5 Âµ) as stationary phase with a mobile phase consisting of methanol: water in the ratio of 95:5% v/v at a flow rate of 1 mL/min and UV detection at 230 nm.
Results: The retention times were observed to be 1.983, 2.525, 3.108, 3.867 and 7.833 minutes for Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol, respectively. The method was statistically validated for linearity, recovery, the limit of detection, limit of quantification, accuracy and precision.
Conclusion: Thus, proposed method was found sensitive, precise, accurate and specific and be used for quantitative estimation of Aspirin, Ramipril, hydrochlorothiazide, Simvastatin and Atenolol in commercial pharmaceutical dosage form.
2. Gaziano TA, H Opie L, Weinstein MC, Cardiovascular disease prevention with a multidrug regimen in the developing world: a cost eï¬€ectiveness analysis. The Lancet 2006;368:679â€“86.
3. Bhatia NM, Gurav SB, Jadhav SD, Bhatia MS, RP-HPLC method for simultaneous estimation of atorvastatin calcium, losartan potassium, atenolol and aspirin from tablet dosage form and plasma. J Liquid Chromatography Related Technologies 2012;35:428â€“43.
4. Vane JR, Botting RM. Review article: the mechanism of action of aspirin. Thrombosis Res 2003;110:255â€“8.
5. http: //www.drugbank.ca/drugs/DB00178.
6. http: //www.drugbank.ca/drugs/DB00999.
7. http: //www.rxlist.com/zocor-drug/clinical-pharmacology. htm.
8. http: //www.medicalfaq.net/mechanism of action/ta-28508.
9. Patel GF, Vekariya NR, Dholakiya RB. Estimation of aspirin and atorvastatin calcium in combined dosage form using derivative spectrophotometric method. Int J Pharm Res 2010;2 (1):62â€“6.
10. Ismail RR, Ganesh M, Jagadeeswaran M, Srinivasan, K, Valarmathi J, Sivakumar T. RP-HPLC method for the simultaneous determination of aspirin, atorvastatin and pioglitazone in capsuled form. Asian J Res Chem 2008;1(1):40â€“2.
11. Gandhimathi M, Ravi T K, Abraham A, Thomas R. Simultaneous determination of aspirin and isosorbide 5-mononitrate in formulation by reversed phase high pressure liquid chromatography. J Pharm Biomed Anal 2003;32:1145â€“8.
12. Yamamoto E, Takakuwa S, Kato T, Asakawa N. Sensitive determination of aspirin and its metabolites in plasma by lc-uv using online solid phase extraction with methyl cellulose immobilized anionâ€“exchange restricted access media. J Chromatogr B 2007;846 (1â€“2): 132â€“138.
13. Walter LJ, Biggs DF, Coutts RT. Simultaneous glc estimation of salicylic acid and aspirin in plasma. J Pharm Sci 1974;63(11):1754â€“8.
14. Cesar J, Ronei LA, Poppi J. Simultaneous determination of acetylsalicylic acid, paracetamol and caffeine using solid-phase molecular fluorescence and parallel factor analysis. Anal Chim Acta 2009;642:212â€“6.
15. Kalyana B, Ramu K, Raghubabu. Development and validation of ramipril estimation from capsules using visible spectrophotometric method. Int J Chem Res 2011;2(2):16-9.
16. Kurade VP, Pai MG, Gude R. RP-HPLC estimation of ramipril and telmisartan in tablets. Indian J Pharm Sci 2009;71(2):148â€“51.
17. Aboul-Enein HY, Thiffault C, Determination of ramipril and its precursors by reversed phase high performance liquid chromatography. Anal Lett 1991;24:2217â€“24.
18. Motofumi I, Takeo K, Junichi G, Toshio N, Separation of ramipril optical isomers by high-performance liquid chromatography. J Liq Chromatogr 1990;13:991â€“1000.
19. Wayadande JA, Dubey R, Bhusari VK, Dhaneshwar SR. Validated HPTLC method for simultaneous estimation of ramipril and metolazone in bulk drug and formulation. Der Pharm Sinica 2011;2(5):273-81.
20. Sahu R, Patel VB, Simultaneous spectrophotometric estimation of hydrochlorothiazide and bisoprolol fumarate in combined dosage forms. Indian J Pharm Sci 2006;68(6):764-7.
21. Stolarczyk M, Masalanka A, Krzek J, Milczarek J. Application of derivative spectrophotometry for determination of enalapril, hydrochlorothiazide and valsartan in complex pharmaceutical preparations. Acta Poloniae Pharm Drug Res 2008;65(3):275-81.
22. Bhusari KP, Khedekar PB, Dhole S, Banode VS. Derivative and Q-analysis spectrophotometric methods for estimation of hydrochlorothiazide and olmesartan medoxomil in tablets. Indian J Pharm Sci 2009;71(5):505â€“8.
23. Tian DF, Tian XL, Tian T, Wang ZY, Mo FK. Simultaneous determination of valsartan and hydrochlorothiazide in tablets by RP-HPLC. Indian J Pharm Sci 2008;70(3):372â€“4.
24. Hao Li, Yingwu Wang, Yao Jiang, Yunbiao Tang, Jiang Wang, Limei Zhao, et al. A liquid chromatography/ tandem mass spectrometry method for the simultaneous quantification of valsartan and hydrochlorothiazide in human plasma. J Chromatogr B 2007;852(1-2):436-42.
25. Bhat LR, Godge RK, Vora AT, Damle MC. Validated RPâ€HPLC method for simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical formulation. J Liquid Chromatography Rel Technol 2007;30(20):3059-67.
26. Patel LJ, Suhagia BN, Shah PB, Shah RR. Simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form by RP-HPLC method. Indian J Pharm Sci 2006;68(5): 635-8.
27. Daniels SL, Vanderwielen AJ. Stabilityâ€“indicating assay for hydrochlorothiazide. J Pharm Sci 1981;70(2):211-5.
28. Naga Raju K, Sudheer Babu I, Jyothi R, Prathyusha S. Spectrophotometric methods for estimation of simvastatin in bulk drug and its dosage form. Int J Pharm Chem Biol Sci 2012;2(1):124-9.
29. Jain N, Jain R, Swami H, Jain DK. RP-HPLC method for simultaneous estimation of simvastatin and ezetimibe in bulk drug and its combined dosage form. Asian J Res Chem 2008;1(1):29-31.
30. Shrestha B, Stephenrathinaraj B, Patel SS, Verma NK, Mazumder R. Simultaneous HPTLC estimation of simvastatin and ezetimibe in tablet dosage form. J Chem 2010;7(4):1206-11.
31. Kasture AV, Ramteke M, Simultaneous UV-spectrophotometric method for the estimation of atenolol and amlodipine besylate in combined dosage form. Indian J Pharm Sci 2006;68(3):394-6.
32. Al-Ghannam SM, A simple spectrophotometric method for the determination of Î²-blockers in dosage forms. J Pharm Biomed Anal 2006;40(1):151-6.
33. Barman R, Islam MA, Ahmed M, Wahed M I I, Islam R, Khan A, Hossain M B, et al. Simultaneous High-Performance liquid chromatographic determination of atenolol and amlodipine in pharmaceutical dosage form. Pakistan J Pharm Sci 2007;20(4):274â€“9.
34. Sathe SR, Bari SB. Simultaneous analysis of losartan potassium, atenolol and hydrochlorothiazide in bulk and in tablets by high-performance thin-layer chromatography with uv absorption densitometry. Acta Chromatogr 2007;19:270â€“8.
35. Rao DD, Satyanarayana NV, Sait SS, Reddy YR, Mukkanti K. Simultaneous determination of losartan potassium, atenolol and hydrochlorothiazide in pharmaceutical preparations by stability-indicating UPLC. Chromatographia 2009;70(3â€“4):647-51.
36. Lamprecht G, Kraushofer T, Stoschitzky K, Lidner W. Enantioselective analaysis of (R)-and (S)-atenolol in urine samples by high-performance liquid chromatography column switching set-up. J Chromatogr B Biomed Sci Appl 2000;740(2):219-26.
37. Prajapati JP, Patel AI, Patel MB, Prajapati RJ. Simultaneous determination of ramipril, atenolol, hydrochlorothiazide, simvastatin and aspirin in ramipril, atenolol, hydrochlorothiazide, simvastatin as tablets and aspirin as enteric coated tablets in capsules by RP-HPLC. Int J Pharm 2012;1(2):95-100.
38. Murthy RS, Ravi Kumar M, Useni Reddy Mallu, Hanimi Reddy Bapatu. A Simple RP-HPLC method for simultaneous analysis of aspirin, atenolol, hydrochlorothiazide, ramipril and simvastatin in pharmaceutical solid dosage forms. Int J Sci Innovations Discoveries 2012;2(1):137-51.
39. ICH, Q2B. Validation of Analytical Procedure: Methodology. International Conference on Harmonisation, IFPMA, Geneva; 2005.