SIMULTANEOUS ESTIMATION OF FEBUXOSTAT AND NAPROXEN IN SYNTHETIC MIXTURE BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

Authors

  • M. s. Krupa Thula (Head of the Department) L. J. Institute of Pharmacy, S.G. Road, Ahmedabad-382210
  • Patel Reshma A. (Head of the Department) L. J. Institute of Pharmacy, S.G. Road, Ahmedabad-382210
  • Dilip G. Maheshwari (Head of the Department) L. J. Institute of Pharmacy, S.G. Road, Ahmedabad-382210

Keywords:

Febuxostat, Naproxen, RP-HPLC, Synthetic mixture

Abstract

Objective: To develop simple, precise, rapid, and accurate RP-HPLC method for the simultaneous estimation of Febuxostat and Naproxen in synthetic mixture. To perform complete validation of newly developed analytical methods as per ICH(Q2) R1 [32] Guideline.

Methods: In RP-HPLC method for Febuxostat and Naproxen, chromatographic separation was carried out on Shimandzu LC-20AT, Hypersil BDS column (250mm x 4.6mm, 5 μm) using mobile phase ACN: Methanol: Phosphate Buffer (50:35:15 v/v) pH 5, detected at 288 nm, with flow rate 1.0ml/min and injection volume 20 μL.

Results: For RP- HPLC Linearity of Febuxostat and Naproxen were found to be 4 – 12 μg/ml and 25 - 75 μg/ml respectively. For both the developed and validated methods the %RSD was found to be less than 2% and the % recovery was found to between 98-102 %.

Conclusion: The developed and validated method was found to be simple, accurate, economical, robust and reproducible. There was no interference of any diluent and excipient in the determination of drugs from synthetic mixture. So, the method can be successfully applied for routine Quality control analysis.

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References

Tripathi K. D, Essentials of Medical Pharmacology, sixth edition, Jaypee Publications, p. Biotechnol Lett;2006:351-64.

Pharmacopoeia NF. United State The Standard of quality, The official compendia of standard, Asian edition, volume no. p124volume no301133904 2009;32(1).

Indian Pharmacopoeia, volume I,II,III, Government of India, Ministry of Health and family welfare.

Rajan D, Srinivasan R, Kumarappan C, Shamala N, V. U. Senthil Development And Validation Of Method For The estimation Of Naproxen In Bulk And Semi-Solid Formulationâ€, International Journal of Analytical, Pharmaceutical, and Bio-medical Sciences, Volume:Issue-1:Jan-Mar-Copyrights@ ISSN: Received: 15th Feb-Revised:20th Feb-Accepted:28th Feb-Coden:IJAPBS www. ijapbscom 2013;2:2278-0246.

Nisha C, Inamullah S, Jyoti R, Sunil S, Sharma S, Hemendar G. Simultaneous estimation of Lansoprazole and Naproxenâ€, Scholars Research Library Der Pharma Chemica,,:(http:// derpharmachemica.com/archive.html)2013. 67-74 p.

Chandrakant S, Abhishek P, Sadhana R, ChemTech USA, Research C. Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Naproxen and Esomeprazole Magnesiumtrihydrate in Combined Pharmaceutical Formulationâ€, International Journal of:IJCRGG ISSN:Vol. No.2, pp 602-608. Biotechnol Lett;4:0974-4290.

Tasnuva H, Mesbah K, Fatema L, Uddin T, Susmita L, Abul K, et al. Md. Kabir;†Simultaneous Estimation of Naproxen and Ranitidine HCl by Using, Stamford Journal of Pharmaceutical Pharm. Sci;1(1&2):18-24.

Paramdeep B, Abdul A, Tariq M, Salman HH, Kuldeep S, A., et al. Mohd Siddiqui, and Method For The Determination Of Febuxostat In Bulk And Pharmaceutical Formulationsâ€, International journal of Pharmaceutical Sciences and, Vol. Issue 10, 28 September. Biotechnol Lett 2011;2.

Sudhir M, Rama R, Venkata R, A., Hplc, Research C. RP-for the Estimation of Febuxostat in Bulk Drugsâ€, International Journal of PharmTech (USA):IJPRIF ISSN:Vol. No.4, pp 1358-1366. Biotechnol Lett;4:0974-4304.

Snyder LR, Kirkland JJ, Dolan JW. and Introduction to Modern Liquid Chromatography;3rd Edn;p. Biotechnol Lett:516-7.

Naresh M, Chandra R, Chandra K, Tablets H, By RP. Estimation Of Related Substances Of Febuxostat In Bulk & 40/80/120mg, International Journal of Pharmaceutical Biological and Chemical Sciences. Biotechnol Lett.

Rahul S, Ravi K, Patnaik K, Hplc. A RP-Development And Validation For The Estimation Of Febuxostat In Bulk And Pharmaceutical Dosage Formâ€, International Research Journal of Pharmacy. Biotechnol Lett.

Kumaraswamy G, J., Venkatesh G, Spandana R, A., Hplc, et al. D. Bhikshapathi, RP-For Simultaneous Estimation Of Febuxostat And Ketorolac Tromethamine in Pharmaceutical Formulationsâ€, Journal of Drug Delivery & Therapeutics;,:173 ©, JDDT. All Rights 2250-1177 CODEN:online at http://jddtonline.info2011. 173-6 p.

Frida D, Volume A. Lotfi Monser, Simultaneous determination of naproxen and related compounds by HPLC using porous graphitic carbon columnâ€;Journal of Pharmaceutical and Biomedical,August,pp no. 10871092 2003;32:4-5.

Udo H Analysis of anti-inflammatory drugs by HPLCâ€;Agilent technologies [Accessed:feb 2014].

Pakhuri M, Chandra S. Development and validation of related substances method by HPLC for analysis of Naproxen in Naproxen tablet formulationsâ€, International journal of Pharmaceutical Sciences and drug research. Biotechnol Lett 2012.

Parvin Z, Mohammad B, Hosniyeh T, Yadollah A, Hadi V. Simultaneous determination of Naproxen, Ketoprofen and Phenol Red in samples from rat intestinal permeability studies:HPLC method development and validationâ€. Biotechnol Lett.

Minakshi P, Pooja C, Shubhini S. Simultaneous Estimation of Sumatriptan Succinate, Naproxen and Domperidone by Reverse Phase High Performance Liquid Chromatographyâ€, Asian Journal of Pharmaceutical and Clinical ResearchVol Suppl 3, ISSN. Biotechnol Lett 2012;5:0974-2441.

Rajnish KN, Asraf SAKS, Manju N, Gunasekaran P. Functional characterization of a putative β-lactamase gene in the genome of Zymomonas mobilis. Biotechnol Lett 2011;33(12):2425-30.

Mahesh N, Harshini A, Sciences I, Chemical P. S. Manikantar and V. Prakash Diwan Reverse Phase High Performance Liquid Chromatographic Estimation Of AntiGout In Pharmaceutical Dosage Form International Journal Of Biological Available online at wwwijpcbscom 2012;3(1):137-42.

Nageswara R, Lakshmana R, Of RP, Hplc, Chemistry I. S. Ganapaty and Development And Validation For Estimation Of Febuxostat In Bulk And Tablet Dosage Formâ€, International Journal Of Research In Pharmacy And,, Available online at www. ijrpccom 2012;2(4).

Sudhir M, Rama R, Venkata R, A., Hplc, Research C. RP-for the Estimation of Febuxostat in Bulk Drugsâ€, International Journal of PharmTech (USA):IJPRIF ISSN:Vol. No.4, pp 1358-1366, Oct-Dec. Biotechnol Lett 2012;4:0974-4304.

Bhalekar R, Sciences I. Sameer Lakade, Minal. H;Developed And Validated Reverse Phase Hplc Method For The Determinationof Febuxostat In Bulk And Formulationsâ€, International Journal of Pharmacy and Pharmaceutical Vol Issue 4. Biotechnol Lett 2012;4:0975-1491.

Ashwini G, Karnaker R, Anand K. N.Aravindsai, †Estimation of Febuxostat drug present in formulation by RP-HPLCâ€, Journal of Pharmacy Research,,-1227Research ArticleISSN:0974-6943 Available online through www. jpronlineinfo Received on1011 Revised on 1512 Accepted on1201 2012;5(2):1224-12271224.

Babu R, Chandu K, Prakash K, Mukkanti K, Nagiat T. Bioequivalance and pharmacokinetic study of Febuxostat in human plasma by using LC-MS/MSwith liquid liquid extraction methodâ€, Springer Plus, 194 http:// www.springerplus.com/ content/2/1/1942013.

Haidong W, Pan D, Xiaoyan C, Lixia G, Dafang Z. Development and validation of a liquid chromatography-tandem mass spectrometry method for the determination of Febuxostatin human plasmaâ€, Received:16 February Revised:11 March, Accepted:11 March Published online in Wiley Online Library:24 May (wileyonlinelibrary.com) DOI 102012.

Naresh M, Chandra R, Chandra K, Tablets H, By RP. Estimation Of Related Substances Of Febuxostat In Bulk & 40/80/120mg, International Journal of Pharmaceutical Biological and Chemical Sciences [Accessed:Oct ]. Biotechnol Lett 2013.

Rahul S, Ravi K, Patnaik K, Hplc. A RP-Development And Validation For The Estimation Of Febuxostat In Bulk And Pharmaceutical Dosage Formâ€, International Research Journal of Pharmacy [Accessed:Oct ]. Biotechnol Lett 2013.

Kumaraswamy G, J., Venkatesh G, Spandana R, A., Hplc, et al. D. Bhikshapathi, RP-For Simultaneous Estimation Of Febuxostat And Ketorolac Tromethamine in Pharmaceutical Formulationsâ€, Journal of Drug Delivery & Therapeutics;,:173 ©, JDDT. All Rights 2250-1177 CODEN:online at http:// jddtonline.info2011. 173-6 p.

HardikSinh P, Hardik M, Priyanka P, Sanjay P, Kruanl C, Of RP, et al. B.Priyanka, Development And Validation For Simultaneous Estimation Of Febuxostat And Diclofenac Potassium In Bulk And Tablet Dosage Formâ€, Inventi Rapid:Pharm Analysis & Quality Assurance publication date:/1/7. Biotechnol Lett 2013.

Vaibhav M, Mohit R, Of RP, Hplc. S. Sadhana, Validation For Simultaneous Estimation Of Febuxostat And Diclofenac Potassium In Bulk Drug And In Bi-Layer Tablet Formulationâ€, International Research Journal of Pharmacy. Biotechnol Lett.

International M, Harmonization I. ICH, Q2B(R1) Validation of Analytical Procedure;on Geneva, Switzerland. Biotechnol Lett 2005.

Published

01-07-2014

How to Cite

Thula, M. s. K., P. Reshma A., and D. G. Maheshwari. “SIMULTANEOUS ESTIMATION OF FEBUXOSTAT AND NAPROXEN IN SYNTHETIC MIXTURE BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 7, July 2014, pp. 470-4, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/1742.

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