DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF LIDOCAINE AND PRILOCAINE IN TOPICAL FORMULATION

Authors

  • Narendra M Gowekar Department of Pharmaceutical Chemistry, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri,Nanded - 431 606, Maharashtra, India
  • Shailesh J Wadher Department of Pharmaceutical Chemistry, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded - 431 606, Maharashtra, India

DOI:

https://doi.org/10.22159/ajpcr.2017.v10i10.15162

Keywords:

High-performance liquid chromatography, Prilocaine, Lidocaine, Validation

Abstract

 

 Objective: A simple, specific, accurate, and precise method, namely, reverse phase high-performance liquid chromatography was to develop for simultaneous estimation of Lidocaine (LDC) and prilocaine (PLC) in a topical local anesthetic cream.

Method: The mixture of PLC and LDC was separated on Hi Q Sil C18 HS column, (250 mm × 4.6 mm, 5 μm), column temperature ambient and flow rate 1.2 mL/minutes. The mobile phase was acetonitrile: 0.01 M diethylamine solution (pH adjusts to 6.8 with orthophosphoric acid) (60:40) with detection at 225 nm.

Results: The retention time was found to be 6.075±0.12 minutes for PLC and 8.642±0.15 minutes for LDC, respectively. Linearity was observed in the concentration range of 1-6 μg/mL for both LDC and PLC, respectively. The method was validated according to International Conference on Harmonization guideline and values of linearity, precision, robustness, limit of detection, limit of quantitation, selectivity, and recovery were found to be in good accordance with the prescribed value.

Conclusion: The proposed method can be useful in the quality control of LDC and PLC in their topical formulation.

Downloads

Download data is not yet available.

References

Powell MF, Hydrochloride LL. Analytical Profiles of Drug Substances. Vol. 15. New York: Academic Press; 1986. p. 761-79.

Rishiraj B, Epstein JB, Fine D, Nabi S, Wade NK. Permanent vision loss in one eye following administration of local anesthesia for a dental extraction. Int J Oral Maxillofac Surg 2005;34(2):220-3.

Warren RE, Van de Mark TB, Weinberg S. Methemoglobinemia induced by high doses of prilocaine. Oral Surg Oral Med Oral Pathol 1974;37(6):866-71.

Karthikkumar B, Thiruvengadarajan VS, Begum NT. Analytical method development and validation of lidocaine in ointment Formulation by UV spectrophotometric method. Int J Pharm Sci 2012;4(2):610-4.

Rizk MS, Issa YM, Shoukry AF, Atia EM. Spectrophotometric determination of lignocaine in pure form and pharmaceutical preparations. Anal Lett 1997;30(15):2743-53.

Atila A, Kadioglu Y. Determination of prilocaine HCl in pharmaceutical preparation and human plasma with spectrophotometry. Int J Pharm Sci Res 2012;3(4):1018-21.

Liawruangrath S, Liawruangrath B, Pibool P. Simultaneous determination of tolperisone and lidocaine by high performance liquid chromatography. J Pharm Biomed Anal 2001;26(5-6):865-72.

Malenovic A, Medenica M, Ivanovic D, Jancic B, Markovic S. Development and validation of RP-HPLC method for cetrimonium bromide and lidocaine determination II. Farmacologiche 2005;60(2):157-61.

Mohammad MA. LC determination of lidocaine and prilocaine containing potential risky impurities and application pharmaceuticals. Chromatographia 2009;70(3):563-8.

Pendela M, Kahsay G, Baekelandt I, Van Schepdael A, Adams E. Simultaneous determination of lidocaine hydrochloride, hydrocortisone and nystatin in a pharmaceutical preparation by RP-LC. J Pharm Biomed Anal 2011;56(3):641-4.

Junior ER, Bentley MV, Lopes LB, Marchetti JM. HPLC assay of lidocaine in vitro dissolution test of the poloxamer 407 gels. Braz J Pharm Sci 2002;38(1):107-11.

Plenis A, Konieczna L, Miekus N, Baczek T. Development of the HPLC method for simultaneous determination of lidocaine hydrochloride and tribenoside along with their impurities supported by the QSRR approach. Chromatographia 2013;76(5-6):255-65.

Klein J, Fernandes D, Gazarian M, Kent G, Koren G. Simultaneous determination of lidocaine, prilocaine and the prilocaine metabolite o-toluidine in plasma by high performance liquid chromatography. J Chromatogr B Biomed Appl 1994;655(1):83-8.

Wiberg K, Jacobsson SP. Parallel factor analysis of HPLC DAD data for binary mixtures of lidocaine and prilocaine with different levels of chromatographic separation. Anal Chim Acta 2004;514(2):203-9.

Storms ML, Stewart JT. Stability-indicating HPLC assays for the determination of prilocaine and procaine drug combinations. J Pharm Biomed Anal 2002;30(1):49-58.

Fijalek Z, Baczynski E, Piwonska A, Warowna-Grzeskiewicz M. Determination of local anaesthetics and their impurities in pharmaceutical preparations using HPLC method with amperometric detection. J Pharm Biomed Anal 2005;37(5):913-8.

Zylber-Katz E, Granit L, Levy M. Gas-liquid chromatographic determination of bupivacaine and lidocaine in plasma. Clin Chem 1978;24(9):1573-5.

Kadioglu Y, Atila A. GC determination of prilocaine HCl in human plasma: Analytical application to real samples. Chromatographia 2008;67:754-9.

Weijden E, van den Broek MP, Ververs FF. Easy and fast LC-MS/MS determination of lidocaine and MEGX in plasma for therapeutic drug monitoring in neonates with seizures. J Chromatogr B 2012;881-882:111-4.

Bo LD, Mazzucchelli P, Marzo A. Highly sensitive bioassay of lidocaine in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr A 1999;854(1-2):3-11.

Koehler A, Oertel R, Kirch W. Simultaneous determination of bupivacaine, mepivacain, prilocaine and ropivacain in human serum by liquid chromatography-tandem mass spectrometry. J Chromatogr A 2005;1088(1-2):126-30.

Watanabe T, Namera A, Yashiki M, Iwasaki Y, Kojima T. Simple analysis of local an aesthetics in human blood using headspace solid- phase micro extraction and gas chromatography-mass spectrometry-electron impact ionization selected ion monitoring. J Chromatogr B 1998;709(2):225-32.

Yang Y, Zhang W, Ye L. Simultaneous determination of prilocaine and lidocaine in transdermal receiving fluid using gas chromatography-mass spectrometry. Chin J Chromatogr 2009;27(1):74-7.

Kadioglu Y, Atila A. Development and validation of gas chromatography-mass spectroscopy method for determination of prilocaine HCl in human plasma using internal standard methodology. Biomed Chromatogr 2007;21(10):1077-82.

Siluveru M, Stewart JT. Stereo selective determination of R (−) and S (+) prilocaine in human serum by capillary electrophoresis using a derivatizedcyclodextrin and ultraviolet detection. J Chromatogr B Biomed Sci Appl 1997;693(1):205-10.

International Conference on Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures-Test and Methodology. Geneva, Switzerland; 2005

Published

01-10-2017

How to Cite

M Gowekar, N., and S. J. Wadher. “DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF LIDOCAINE AND PRILOCAINE IN TOPICAL FORMULATION”. Asian Journal of Pharmaceutical and Clinical Research, vol. 10, no. 10, Oct. 2017, pp. 189-2, doi:10.22159/ajpcr.2017.v10i10.15162.

Issue

Section

Original Article(s)