Development and Validation of Reverse Phase-HPLC Method for Estimation of Aceclofenac and Rabeprazole Sodium in Bulk and Combined Dosage Form

Authors

  • Rajani N. Jinde Student, Department of Clinical Research, CRB Tech, Pune. India
  • Pathan Azhar Khan Trainer, Department of Clinical Research, CRB Tech, Pune, India
  • Manadar Abhyankar Director, CRB Tech, Pune. India
  • Megha Jadhav Department of Quality Assurance, P. Wadhwani College of Pharmacy, Yavatmal, India

DOI:

https://doi.org/10.56511/JIPBS.2015.v2.i01.pp17-23

Abstract

The present work describes a validated reverse phase high performance liquid chromatographic method involved with diode array detection for simultaneous estimation of Rabeprazole sodium (RAB) and Aceclofenac (ACL) in combined dosage form. Chromatographic separation was performed on ProntosilC18(4.6 id x 250 mm 5µm particle size) Column with mobile phase consisting  methanol: water pH 2.5 (75:25 v/v).The flow rate was 1.0 ml/min and eluents were monitored at 273nm by using Photo Diode Array(PDA) detector at ambient temperature. The separation of both drug were found effectively on 3.23min of RAB and 7.78min of ACL with total run time upto10 minutes. The proposed method was found to be simple as was involved with water as mobile phase component it was fast, accurate, precise, reproducible, linear, robust and rugged which have been further used for simultaneous analysis of RAB and ACL in combined pharmaceutical formulations. 

Keywords:

Rabeprazole sodium, Aceclofenac, Reversed phase- HPLC, PDA

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References

Sahu D., Agrawal Y.P., Sabrawal N., Jain A. & Gupta A.K ., Simultaneous Estimation of Aceclofenac&Rabeprazole Sodium In Solid Dosage Form, Asian Journal of Biochemical and Pharmaceutical Research Issue 3 (Vol. 1) 2011 ISSN: 2231 - 2560.

Kulkarni V.L. and MahulikarP.P. ,Estimation of Rabeprazole sodium in tablet dosage form by rapid isocratic reversed phaseHPLC using volatile buffer additives , Journal of Scientific and Industrial Research Vol 65, December 2006,pp 992-994.

Bharekar V.V., Mulla T.S., Yadav S.S., Rajput M.P. and Rao J.R. , Validated HPTLC method for simultaneous estimation of rabeprazole sodium and aceclofenac in bulk drug and formulation,Rao J R et al. / PharmacieGlobale (IJCP) 2011, 5 (06) ISSN 0976-8157.

Godse V.P.,Deodhar M.N., Bhosale A.V., Sonawane R.A., Sakpal P.S., Borkar D.D. and Bafana Y.S.,Reverse Phase HPLC Method for Determination of Aceclofenac and Paracetamol in Tablet Dosage Form, Asian J. Research Chem.. 2(1): Jan..-Mar. 2009.

Ramadan N.K., Heba M.M. and Azza A.M., Simultaneous determination of Rabeprazole sodium and Domperidone, Journal of Applied Pharmaceutical Science 01 (09); 2011: 73-80, ISSN: 2231-3354

Mandhanya M., Dubey N., Chaturvedi S.C., Jain D.K., Simultaneously Estimation of Paracetamol, Aceclofenac and Rabeprazole in Tablet Dosage Form Using UV Spectroscopy, Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423.

Christian G.D., Analytical Chemistry. 6 th edition, John Wiley and Sons, Inc., 2007,2,5,35-42,127-132

Skoog D.A., Holler F.J., Niemen T.A., Principle of Instrumental Analysis. 5 th edition, Harcourt Publications, India, 2007.2.

Willard H.H., Dean J.A., Settle F.A., Merritt L.L., Instrumental method analysis,7 th edition, CBS publishers & distributers New Delhi,1-4 .

Sethi P.D., ‘High Performance Liquid Chromatography’, Quantitative Analysis of Pharmaceutical Formulations, 1 st edition, CBS Publishers and Distributors, New Delhi, 2001,Page no-8-9,11-12

Beckett A.H., Stenlake J.B., Practical Pharmaceutical Chemistry 4 th edition. CBS Publishers and Distributors, New Delhi, 278282.

Chatwal G.R., Anand S.K., Instrumental Methods of Chemical Analysis, 5 th edition, Himalaya Publishing House, Mumbai,2008.

Kasture A.V., Mahadik K.R., Wadodkar S.G., More H.N., Pharmaceutical AnalysisInstrumental Methods, Vol – II.

Sharma B.K., Instrumental Methods of Chemical Analysis.25 th ed. Goel Publishing House, Meerut, 1983.

Sharma S.K., Validation of pharmaceutical products & processes, 2003.

Snyder L.R., Kirkland J.J., Practical HPLC Method Development, Wiley inter science publication, New York. 1997, 2,686-772.

United State Pharmacopoeia 32 NF 27, Volume - 2 Page No.3639

Indian Pharmacopoeia, Government of India, Ministry of Health and Family welfare, Delhi, 2007,143,159.

Michel W.D., Modern HPLC for practicing scientist, A John Wiley & Sons, Inc., Publication, Page No. 194,217

Gennaro A.R.., Karan B.M.., Medwick T., Remington: The Science And Practice Of Pharmacy, 19 th Edn., Vol - 1, The Mark Publishing Company, Pennylvania

FDA, “International Conference on Harmonization: Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products,” (21 April 2000) Federal Register 65 (78), 21446 – 21453[ICH Q1A(R)].

ICH Harmonised Tripartite Guideline (Nov 2005) Val idation of Analytical Procedures: Text and Methodology, Q2 (R1).

Sahu D., Agrawal Y.P., Sabrawal N., Jain A. & Gupta A.K., Simultaneous Estimation of Aceclofenac&Rabeprazole Sodium In Solid Dosage Form, Asian Journal of Biochemical and Pharmaceutical Research Issue 3 (Vol. 1) 2011 ISSN: 2231-2560.

Kulkarni V.L. and MahulikarP.P. ,Estimation of Rabeprazole sodium in tablet dosage form by rapid isocratic reversed phaseHPLC using volatile buffer additives , Journal of Scientific and Industrial Research Vol 65, December 2006,pp 992-994.

Bharekar V.V., Mulla T.S., Yadav S.S., Rajput M.P. and Rao J.R. , Validated HPTLC method for simultaneous estimation of rabeprazole sodium and aceclofenac in bulk drug and formulation,Rao J R et al. / PharmacieGlobale (IJCP) 2011, 5 (06) ISSN 0976-8157.

Godse V.P.,Deodhar M.N., Bhosale A.V., Sonawane R.A., Sakpal P.S., Borkar D.D. and Bafana Y.S.,Reverse Phase HPLC Method for Determination of Aceclofenac and Paracetamol in Tablet Dosage Form, Asian J. Research Chem.. 2(1): Jan..-Mar. 2009.

Ramadan N.K., Heba M.M. and Azza A.M., Simultaneous determination of Rabeprazole sodium and Domperidone, Journal of Applied Pharmaceutical Science 01 (09); 2011: 73-80, ISSN: 2231-3354

Mandhanya M., Dubey N., Chaturvedi S.C., Jain D.K., Simultaneously Estimation of Paracetamol, Aceclofenac and Rabeprazole in Tablet Dosage Form Using UV Spectroscopy, Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423.

Reddy M.K.O., Bodepudi C., Shanmugasundaram P., Method Development and Validation of Rabeprazole in Bulk and Tablet dosage form by RP-HPLC Method, International Journal of ChemTech Research CODEN( USA): IJCRGG ISSN : 0974-4290 Vol. 3, No.3, pp 1580-1588, July-Sept 2011.

Shirish R.P., Patel L.J. , Thakkar Y.P., Patel N.D., Development and Validation of analytical method for the determination of Rabeprazole and Ondansetron in pharmaceutical dosage form by Reversedphase HPLC, International Journal of ChemTech Research CODEN( USA): IJCRGG ISSN : 0974-4290 Vol.2, No.3, pp 1531-1536, July-Sept 2010.

Gopinath R., Rajan S., Meyyanathan S.N., A RP-HPLC method for simultaneous estimation of paracetamol and aceclofenac in tablets, Indian Journal of Pharmaceutical sciences Year : 2007 Volume : 69 Issue : 1 : 137-140.

Bharekar V.V., Mulla T.S., Rajput M.P., Validated HPTLC method for simultaneous estimation of Rabeprazole Sodium, Paraetamol and Aceclofenac in bulk drug and formulation, Scholars Research Library Der PharmaChemica, 2011, 3 (4):171-179, ISSN 0975-413X ,CODEN (USA): PCHHAX.

Ravisankar S., Vasudevan M. and Najan M.J., Reverse phase HPLC method for the estimation of Paracetamol,Chlorzoxazonze, and Diclofenac sodium in formulations.Indian Drugs.1997;34 (11):663.

Rao L.A., Ravi Kumar B.N.V. and Sankar G.G. .,Development of RP-HPLC Method for the Estimation of Rabeprazole in Pure and Tablet Dosage Form 2008, 5, 1149-1153.

Reddy B.P.* and Reddy M.S., RP-HPLC Method for Simultaneous Estimation of Paracetamol and Ibuprofen in Tablets.Asian J. Research Chem. 2(1): Jan.-March, 2009,ISSN 0974-4169.

Published

05-01-2015
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How to Cite

Jinde, R. N., P. A. Khan, M. Abhyankar, and M. Jadhav. “Development and Validation of Reverse Phase-HPLC Method for Estimation of Aceclofenac and Rabeprazole Sodium in Bulk and Combined Dosage Form”. Journal of Innovations in Pharmaceutical and Biological Sciences, vol. 2, no. 1, Jan. 2015, pp. 17-23, doi:10.56511/JIPBS.2015.v2.i01.pp17-23.

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Research Article