UV SPECTROPHOTOMETRIC AND RP- HPLC METHODS FOR SIMULTANEOUS ESTIMATION OF ISONIAZID, RIFAMPICIN AND PIPERINE IN PHARMACEUTICAL DOSAGE FORM
Objective: Simple, reliable, sensitive and accurate spectrophotometric and RP-HPLC methods for the estimation of INH, RIFA and PIPE in pure and pharmaceutical dosage form.
Methods: In the first Absorption correction method, methanol and distilled water were used as diluent. The wavelengths selected for the analysis were 262 nm, 338 nm and 477 nm for INH, PIPE and RIFA respectively. The Second RP â€“ HPLC method has been developed using Acetonitrile as diluent. Successful separation of drugs was achieved on LC18 100 Aâ° column (250 x 4.6 mm, 5 Î¼) using 0.01M Sodium Dihydrogen Orthophosphate, pH 6.5 and acetonitrile (40:60, % v/v) as mobile phase with flow rate of 0.9 mL/min. The wavelength of detection was 282 nm. Validation of developed methods was done according to ICH Q2 (R1) guideline.
Results: Calibration curve was linear over the concentration range of 12-34.5 Î¼g/mL (INH), 8-23 Î¼g/mL (RIFA) and 0.4-1.15 Î¼g/mL (PIPE) respectively for absorption correction method and 30- 330 Î¼g/mL (INH), 20-220 Î¼g/mL (RIFA) and 1-11 Î¼g/mL (PIPE) for RP â€“ HPLC method with r2 value greater than 0.995. Accuracy of methods was determined by recovery studies and it was found to be 98 to 102 %. The % RSD values for all the validation parameters were less than 2.0 % for both the methods.
Conclusion: The developed RP-HPLC and UV spectrophotometric method were successfully applied for the quantitative determination of cited drugs in pharmaceutical dosage form.
2. Indian Pharmacopoeia. Government of India Ministry of Health & Family Welfare: The Indian Pharmacopoeia Commission, Ghaziabad, India; 2007. p. 1515-7.
3. British Pharmacopoeia, Government of British: B. P Commission, Stationary Office; 2009:3259-61.
4. The United States Pharmacopeia Drug Information. 18th edition. The United states Pharmacopoeia Convention: Inc. Rockville, Md, USA; 2007:2412-3.
5. European Pharmacopoeia: European Directorate for the Quality of medicines and healthcare; 2011. p. 2285-6.
6. Rang HP, Dale MM, Pitter JM, Flower RJJ. RANG AND DALEâ€™S Pharmacologyâ€. 6th edn. 2007. p. 675.
7. Indian Pharmacopoeia, Government of India Ministry of Health & Family Welfare: The Indian Pharmacopoeia Commission, Ghaziabad, India; 2007. p. 2054-9.
8. Japanese Pharmacopeia, 16th edition. The ministry of Health, Labour and Welfare: Prefectural office in Japan: 2011. p. 1347-50.
9. British Pharmacopoeia, Government of British, B. P Commission: Stationary Office; 2009. p. 5206-9.
10. United States Pharmacopeia, 18th edition. The United states Pharmacopoeia Convention: Inc. Rockville, Md, USA; 2007:3128-9.
11. European Pharmacopoeia: European Directorate for the Quality of medicines and healthcare; 2011:2856-7.
12. Hardman JG, Limbird LE, Alfred GG. Goodman & Gilman's The Pharmacological Basis of Therapeuticsâ€, 10th edn; 2006. p. 1273.
13. Indian Pharmacopoeia, Government of India Ministry of Health & Family Welfare: The Indian Pharmacopoeia Commission, Ghaziabad, India; 2010. p. 2522-3.
14. Manna A, Datta S, Ghosh PK, Ghosh LK, Gupta BK. Simultaneous estimation of Isoniazid and Rifampicin in combine dosage form. Indian J Pharm Sci 2000;62(3):185-6.
15. Sharma SC, Das S, Talwar SK. Spectrophotometric estimation of Rifampin-Isoniazid mixture in dosage form. J Asso Anal Chem 1987;70(04);679-81.
16. Gupta V, Jain UK. Quantitative analysis of piperine in ayurvedic formulation by UV Spectrophotometry. Inter J Pharm Sci Res 2011;2(02):58-61.
17. Gupta V, Jain UK. Estimation of Piperine by UV-Spectrophotometric method in herbal formulation Pippli Churna. Inter J Res Pharm Biomed Sci 2011;2(02):550-3.
18. Shyam PT, RaoY. Chaithanya Y, Raghavendhra P, Surendar M, Banji D. Method development and validation of RP-HPLC method for simultaneous estimation of Rifampicin, Isoniazid & Pyridoxine hydrochloride in bulk pharmaceutical dosage form. Int J Pharm Res Development 2012;4(08):153-62.
19. Solanki SS, Bhadoriya U, Jain S, Dhanwani RK, Kumar S. Quantitative analysis of Piperine in an ayurvedic formulation using reverse phase high performance liquid chromatography. Asian J Pharm Med Sci 2012;2(01):11-5.
20. Calleja I, Blanco-PrÄ±Ìeto MJ, Ruz N, Renedo MJ, Dios-ViÃ©itez MC. High-performance liquidâ€“chromatographic determination of Rifampicin in plasma and tissues. J Chrom A 2004;1031(1):289-94.
21. Mariappan TT, Singh B, Singh S. A validated Reversed-Phase (C18) HPLC Method for simultaneous determination of rifampicin, isoniazid and pyrazinamide in USP dissolution medium and simulated gastric fluid. Pharm Pharmacol Communications 2000;6(8):345-9.
22. Vyas N, Gamit K, Khan MY, Panchal S, Pundarikakshudu K. Simultaneous estimation of Curcumin and Piperine in their crude powder mixture and ayurvedic formulation using high performance thin layer chromatography. Int J Res Pharm Biomed Sci 2011;2(01):231-6.
23. Tapadiya G, Metku M, Deokate U, Khadabadi S, Saboo S, Sahu K. Quantitative estimation of Piperine from pharmaceutical dosage form by HPTLC. Asian J Pharm Clin Res 2009;2(02):47-50.
24. Shanmugasundaram P, Maheswari R, Vijayaanandhi M. Quantitative estimation of Piperine in herbal cough syrup by HPTLC method. Rasayan J Chem 2008;1(02):212-7.
25. Glass BD, Kustrin SA, Chen YJ, Wisch MH. Optimization of a stability-indicating HPLC method for the simultaneous determination of Rifampicin, Isoniazid and Pyrazinamide in a fixed-dose combination using artificial neural networks. J Chromatographic Sci 2007;45:38-44.
26. Ali J, Sultana Y, Baboota S, Faiyaz S. Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs. Acta Chromatographica 2007;18:168-79.
27. Patil JS, Sarasija S, Sureshbabu AR, Rajesh MS. Development and validation of liquid chromatography-mass spectrometry method for the estimation of Rifampicin in plasma. Indian J Pharm Sci 2011;73(05):558-63.
28. Srivastava A, Waterhouse D, Ardrey A, Ward SA. Quantification of rifampicin in human plasma and cerebrospinal fluid by a highly sensitive and rapid liquid chromatographicâ€“tandem mass spectrometric method. J Pharm Biomed Anal 2012;70:523-8.
29. Patel S, Vyas N. Validated spectrofluorimetric method for estimation of piperine in an ayurvedic formulation. Asian J Pharm Clin Res 2012;5(04):231-3.
30. ICHâ€“Q2 (R1), Guidance on validation of analytical procedure: text and methodology. The Europian Agency for the evalution of medicinal products, Geneva, Switaerland: 2005.
31. Anandakumar K, Jayamariappan M. Absorption correction method for the simultaneous estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in bulk and in combined tablet dosage form. Int J Pharm Pharm Sci 2011;3(01):23-7.