Development and Validation of New High Performance Liquid Chromatography Analytical Technique For Separation of Diclofenac Sodium and Lidocaine Hydrochloride From Ampoule Injection
https://doi.org/10.24017/science.2020.1.11
Abstract views: 1819 / PDF downloads: 811Abstract
In the current investigation, a number of chromatographic methods with the accurate, precise and specific criteria have been developed and validated for diclofenac sodium and lidocaine hydrochloride Commitment of their large quantities ampule of pharmaceutical dosage form. The High-Performance Liquid Chromatography (HPLC) system was performed at 25 ° C; with appropriate chromatographic isolation accomplished through the use of Waters Symmetry SB-C7 column with a mobile phase containing 0.1 M sodium acetate and methanol (40:60) (v/v). During development the portable stage was delivered at a stream rate of 1 mL/min, the wavelength was adjusted at 254 nm. First of all, the retention times for diclofenac sodium and lidocaine HCl were about 4.1 and 10.8 min accordingly. A performance and technical demonstration of the suggested Revers phase-HPLC method has been numerically challenged with support to process appropriateness, verticality, scales, simplicity, repeatability, sensitivity, stability, discovery and limits of quantification. In addition, the calibration curves for diclofenac sodium active pharmaceutical ingredient (API) with linear regressions > 0,999895 obtained linear in the distances 1870-5600 ?g / mL. Moreover, for determining of lidocaine HCl drug, a range of 500 - 1500 ?g/mL of working standard was used, the result showed for lidocain HCl that a linear curve with correlation coefficients of > 0.99980. Finally, the both drugs were isolated and resolute with selective and stable characteristics by the proposed technique. In the conclusion, successful validation of the HPLC approach has been demonstrated with high precision and accuracy for the assessment of both the mixed dosage form type of both diclofenac sodium and lidocaine HCl.
Keywords:
Diclofenac sodium, HCl lidocaine, Reverse phase Higher performance chrmomatography, Simultaneous estimation
References
[1] Sweetman, S.C. ed., 2009. Martindale: the complete drug reference (Vol. 3709). London: Pharmaceutical press.
[2] M. Abdelrahman, M. Adly, W. Ali, S. Abdelwahab, "Development and Validation of Different Spectrophotometric and High-Performance Thin-Layer Chromatographic Methods for the Determination of Fosinopril Sodium, Hydrochlorothiazide, and Chlorothiazide as Hydrochlorothiazide Impurity", JPC-Journal of Planar Chromatography-Modern TLC, 32(5), 411-420, 2019.
https://doi.org/10.1556/1006.2019.32.5.9
[3] K. Thanki, P. Gangwal, T. Sangamwar, S. Jain, "Oral delivery of anticancer drugs: challenges and opportunities". Journal of controlled release, 170(1), 15-40, 2013.
https://doi.org/10.1016/j.jconrel.2013.04.020
[4] R. Sawant, L. Bhangale, R. Joshi, P. Lanke, "Validated spectrophotometric methods for simultaneous estimation of Paracetamol, Domperidone and Tramadol HCl in pure and tablet dosage form". Journal of chemical metrology, 4(1), 21, 2010.
[5] L. Stankevi?i?t?, "Nesteroidini? vaist? nuo uždegimo mišinio tyrimas taikant chromatografinius analiz?s metodus", 2015.
[6] K. Agrawal, K. Shivramchandra, "Spectrophotometric determination of diclofenac sodium in tablets". Journal of pharmaceutical and biomedical analysis, 9(2), 97-100, 1991.
https://doi.org/10.1016/0731-7085(91)80131-R
[7] W. Ali, "Different spectrophotometric and TLC-densitometric methods for determination of two analgesic drugs". Asian Journal of Biomedical and Pharmaceutical Sciences, 2014.
[8] S. Mazurek, R. Szostak, "Quantitative determination of diclofenac sodium and aminophylline in injection solutions by FT-Raman spectroscopy". Journal of pharmaceutical and biomedical analysis, 40(5), 1235-1242, 2006.
https://doi.org/10.1016/j.jpba.2005.09.019
[9] L. Carreira, M. Rizk, Y. El-Shabrawy, A. Zakhari, S. Toubar, "Europium (III) ion probe spectrofluorometric determination of diclofenac sodium". Journal of pharmaceutical and biomedical analysis, 13(11), 1331-1337, 1995.
https://doi.org/10.1016/0731-7085(95)01567-5
[10] A. Castillo, L. Bruzzone, "Indirect fluorometric determination of diclofenac sodium". Analytical Sciences, 22(3), 431-433, 2006.
https://doi.org/10.2116/analsci.22.431
[11] N. Rashid, H. Bakir, O. Baban, "Spectrophotometric determination of Diclofenac Sodium in pure form and in the pharmaceutical preparations". Tikrit Journal of Pure Science, 21(3), 76-80, 2018.
[12] J. Sawchuk, A. Maloney, L. Cartier, J. Rackley, K. Chan, S. Lau, "Analysis of diclofenac and four of its metabolites in human urine by HPLC". Pharmaceutical research, 12(5), 756-762, 1995.
https://doi.org/10.1023/A:1016276012891
[13] F. Khan, I. Ahmad, M. Akhtar, A. Rauf, H. Altaf, M. Hayat, "RP-HPLC method development and validation for simultaneous determination of esomeprazole and diclofenac sodium in pharmaceutical dosage forms". Pharmaceutical Chemistry Journal, 49(11), 788-794, 2016.
https://doi.org/10.1007/s11094-016-1372-7
[14] R. Ahmed, N. Lottfi, "High Performance Liquid Chromatographic Method for the determination of Diclofenac sodium in pharmaceutical preparations and in Environmental Samples". Iraqi National Journal of Chemistry, (44), 467-473, 2011.
[15] M. Davies, E. Anderson, "Clinical pharmacokinetics of diclofenac". Clinical pharmacokinetics, 33(3), 184-213, 1997.
https://doi.org/10.2165/00003088-199733030-00003
[16] W. Jin, J. Zhang, "Determination of diclofenac sodium by capillary zone electrophoresis with electrochemical detection". Journal of Chromatography A, 868(1), 101-107, 2000.
https://doi.org/10.1016/S0021-9673(99)01149-8
[17] E. Abdel-Hamid, L. Novotny, H. Hamza, "Determination of diclofenac sodium, flufenamic acid, indomethacin and ketoprofen by LC-APCI-MS". Journal of pharmaceutical and biomedical analysis, 24(4), 587-594, 2001.
https://doi.org/10.1016/S0731-7085(00)00444-1
[18] A. Saleh, F. Askal, "Spectrophotometric determination of certain local anaesthetics in pharmaceutical preparations". Analytical letters, 28(15), 2663-2671, 1995.
https://doi.org/10.1080/00032719508007417
[19] Ö, Aksu, A. Bozdo?an, G. Kunt, "Simultaneous determination of mepyramine maleate, lidocaine hydrochloride, and dexpanthenol in pharmaceutical preparations by partial least?squares multivariate calibration". Analytical letters, 39(4), 751-761, 2006.
https://doi.org/10.1080/00032710600611210
[20] W. Holt, Y. Loizou, K. Wyse, "Gas-liquid chromatographic measurement of lignocaine in small samples of canine myocardium after enzymatic digestion". Journal of clinical pathology, 32(3), 225-228, 1979.
https://doi.org/10.1136/jcp.32.3.225
[21] W. Ali, S. Abdelwahab, M. Abdelkawy, M. Elgebaly, "Different spectrophotometric and TLC-densitometric methods for determination of diclofenac Na and lidocaine HCl". Beni-Suef, Cairo, Egypt, 3(6), 57-64, 2013.
[22] S. Liawruangrath, B. Liawruangrath, P. Pibool, "Simultaneous determination of tolperisone and lidocaine by high performance liquid chromatography". Journal of pharmaceutical and biomedical analysis, 26(5-6), 865-872, 2001.
https://doi.org/10.1016/S0731-7085(01)00462-9
[23] A. Malenovic, M. Medenica, D. Ivanovic, B. Jancic, S. Markovic, "Development and validation of RP-HPLC method for cetrimonium bromide and lidocaine determination". Il Farmaco, 60(2), 157-161, 2005.
https://doi.org/10.1016/j.farmac.2004.11.004
[24] W. Cao, J. Liu, H. Qiu, X. Yang, E. Wang, "Simultaneous determination of tramadol and lidocaine in urine by end?column capillary electrophoresis with electrochemiluminescence detection". Electroanalysis: An International Journal Devoted to Fundamental and Practical Aspects of Electroanalysis, 14(22), 1571-1576, 2002.
https://doi.org/10.1002/1521-4109(200211)14:22<1571::AID-ELAN1571>3.0.CO;2-X
[25] S. El-Saharty, M. Refaat, Z. El-Khateeb, "Simultaneous determination of diclofenac sodium and diflunisal". Bull Fac Pharm Cairo Univ, 40, 47-64, 2002.
[26] A. Gottschalk, N. Raja, "Severing the Link between Acute and Chronic PainThe Anesthesiologist's Role in Preventive Medicine". Anesthesiology: The Journal of the American Society of Anesthesiologists, 101(5), 1063-1065, 2004.
https://doi.org/10.1097/00000542-200411000-00004
[27] J. Pavlin, C. Chen, A. Penaloza, L. Polissar, P. Buckley, "Pain as a factor complicating recovery and discharge after ambulatory surgery". Anesthesia & Analgesia, 95(3), 627-634, 2002.
https://doi.org/10.1097/00000539-200209000-00025
[28] L. Apfelbaum, C. Chen, S. Mehta, J. Gan, "Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged". Anesthesia & Analgesia, 97(2), 534-540, 2003.
https://doi.org/10.1213/01.ANE.0000068822.10113.9E
[29] L. Vigneault, F. Turgeon, D. Côté, F. Lauzier, R. Zarychanski, L. Moore, A. Fergusson, "Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials". Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 58(1), 22-37, 2011.
https://doi.org/10.1007/s12630-010-9407-0
[30] R. Khoshayand, H. Abdollahi, A. Ghaffari, M. Shariatpanahi, H. Farzanegan, "Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches". Daru: journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 18(4), 292, 2010.
[31] L. Vigneault, F. Turgeon, D. Côté, F. Lauzier, R. Zarychanski, L. Moore, A. Fergusson, "Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials". Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 58(1), 22-37, 2011.
https://doi.org/10.1007/s12630-010-9407-0
[32] R. Khoshayand, H. Abdollahi, A. Ghaffari, M. Shariatpanahi, H. Farzanegan, "Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches". Daru: journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 18(4), 292, 2010.
[33] U. Gasanov, D. Hughes, M. Hansbro, "Methods for the isolation and identification of Listeria spp. and Listeria monocytogenes: a review". FEMS microbiology reviews, 29(5), 851-875, 2005.
https://doi.org/10.1016/j.femsre.2004.12.002
[34] Bhusal, P., Sharma, M., Harrison, J., Procter, G., Andrews, G., Jones, D.S., Hill, A.G. and Svirskis, D., 2017. Development, validation and application of a stability indicating HPLC method to quantify lidocaine from polyethylene-co-vinyl acetate (EVA) matrices and biological fluids. Journal of chromatographic science, 55(8), pp.832-838.
https://doi.org/10.1093/chromsci/bmx043
[35] Belal, T.S., Bedair, M.M., Gazy, A.A. and Guirguis, K.M., 2015. Validated selective HPLC-DAD method for the simultaneous determination of diclofenac sodium and lidocaine hydrochloride in presence of four of their related substances and potential impurities. Acta Chromatographica, 27(3), pp.477-493.
https://doi.org/10.1556/AChrom.27.2015.3.6
[2] M. Abdelrahman, M. Adly, W. Ali, S. Abdelwahab, "Development and Validation of Different Spectrophotometric and High-Performance Thin-Layer Chromatographic Methods for the Determination of Fosinopril Sodium, Hydrochlorothiazide, and Chlorothiazide as Hydrochlorothiazide Impurity", JPC-Journal of Planar Chromatography-Modern TLC, 32(5), 411-420, 2019.
https://doi.org/10.1556/1006.2019.32.5.9
[3] K. Thanki, P. Gangwal, T. Sangamwar, S. Jain, "Oral delivery of anticancer drugs: challenges and opportunities". Journal of controlled release, 170(1), 15-40, 2013.
https://doi.org/10.1016/j.jconrel.2013.04.020
[4] R. Sawant, L. Bhangale, R. Joshi, P. Lanke, "Validated spectrophotometric methods for simultaneous estimation of Paracetamol, Domperidone and Tramadol HCl in pure and tablet dosage form". Journal of chemical metrology, 4(1), 21, 2010.
[5] L. Stankevi?i?t?, "Nesteroidini? vaist? nuo uždegimo mišinio tyrimas taikant chromatografinius analiz?s metodus", 2015.
[6] K. Agrawal, K. Shivramchandra, "Spectrophotometric determination of diclofenac sodium in tablets". Journal of pharmaceutical and biomedical analysis, 9(2), 97-100, 1991.
https://doi.org/10.1016/0731-7085(91)80131-R
[7] W. Ali, "Different spectrophotometric and TLC-densitometric methods for determination of two analgesic drugs". Asian Journal of Biomedical and Pharmaceutical Sciences, 2014.
[8] S. Mazurek, R. Szostak, "Quantitative determination of diclofenac sodium and aminophylline in injection solutions by FT-Raman spectroscopy". Journal of pharmaceutical and biomedical analysis, 40(5), 1235-1242, 2006.
https://doi.org/10.1016/j.jpba.2005.09.019
[9] L. Carreira, M. Rizk, Y. El-Shabrawy, A. Zakhari, S. Toubar, "Europium (III) ion probe spectrofluorometric determination of diclofenac sodium". Journal of pharmaceutical and biomedical analysis, 13(11), 1331-1337, 1995.
https://doi.org/10.1016/0731-7085(95)01567-5
[10] A. Castillo, L. Bruzzone, "Indirect fluorometric determination of diclofenac sodium". Analytical Sciences, 22(3), 431-433, 2006.
https://doi.org/10.2116/analsci.22.431
[11] N. Rashid, H. Bakir, O. Baban, "Spectrophotometric determination of Diclofenac Sodium in pure form and in the pharmaceutical preparations". Tikrit Journal of Pure Science, 21(3), 76-80, 2018.
[12] J. Sawchuk, A. Maloney, L. Cartier, J. Rackley, K. Chan, S. Lau, "Analysis of diclofenac and four of its metabolites in human urine by HPLC". Pharmaceutical research, 12(5), 756-762, 1995.
https://doi.org/10.1023/A:1016276012891
[13] F. Khan, I. Ahmad, M. Akhtar, A. Rauf, H. Altaf, M. Hayat, "RP-HPLC method development and validation for simultaneous determination of esomeprazole and diclofenac sodium in pharmaceutical dosage forms". Pharmaceutical Chemistry Journal, 49(11), 788-794, 2016.
https://doi.org/10.1007/s11094-016-1372-7
[14] R. Ahmed, N. Lottfi, "High Performance Liquid Chromatographic Method for the determination of Diclofenac sodium in pharmaceutical preparations and in Environmental Samples". Iraqi National Journal of Chemistry, (44), 467-473, 2011.
[15] M. Davies, E. Anderson, "Clinical pharmacokinetics of diclofenac". Clinical pharmacokinetics, 33(3), 184-213, 1997.
https://doi.org/10.2165/00003088-199733030-00003
[16] W. Jin, J. Zhang, "Determination of diclofenac sodium by capillary zone electrophoresis with electrochemical detection". Journal of Chromatography A, 868(1), 101-107, 2000.
https://doi.org/10.1016/S0021-9673(99)01149-8
[17] E. Abdel-Hamid, L. Novotny, H. Hamza, "Determination of diclofenac sodium, flufenamic acid, indomethacin and ketoprofen by LC-APCI-MS". Journal of pharmaceutical and biomedical analysis, 24(4), 587-594, 2001.
https://doi.org/10.1016/S0731-7085(00)00444-1
[18] A. Saleh, F. Askal, "Spectrophotometric determination of certain local anaesthetics in pharmaceutical preparations". Analytical letters, 28(15), 2663-2671, 1995.
https://doi.org/10.1080/00032719508007417
[19] Ö, Aksu, A. Bozdo?an, G. Kunt, "Simultaneous determination of mepyramine maleate, lidocaine hydrochloride, and dexpanthenol in pharmaceutical preparations by partial least?squares multivariate calibration". Analytical letters, 39(4), 751-761, 2006.
https://doi.org/10.1080/00032710600611210
[20] W. Holt, Y. Loizou, K. Wyse, "Gas-liquid chromatographic measurement of lignocaine in small samples of canine myocardium after enzymatic digestion". Journal of clinical pathology, 32(3), 225-228, 1979.
https://doi.org/10.1136/jcp.32.3.225
[21] W. Ali, S. Abdelwahab, M. Abdelkawy, M. Elgebaly, "Different spectrophotometric and TLC-densitometric methods for determination of diclofenac Na and lidocaine HCl". Beni-Suef, Cairo, Egypt, 3(6), 57-64, 2013.
[22] S. Liawruangrath, B. Liawruangrath, P. Pibool, "Simultaneous determination of tolperisone and lidocaine by high performance liquid chromatography". Journal of pharmaceutical and biomedical analysis, 26(5-6), 865-872, 2001.
https://doi.org/10.1016/S0731-7085(01)00462-9
[23] A. Malenovic, M. Medenica, D. Ivanovic, B. Jancic, S. Markovic, "Development and validation of RP-HPLC method for cetrimonium bromide and lidocaine determination". Il Farmaco, 60(2), 157-161, 2005.
https://doi.org/10.1016/j.farmac.2004.11.004
[24] W. Cao, J. Liu, H. Qiu, X. Yang, E. Wang, "Simultaneous determination of tramadol and lidocaine in urine by end?column capillary electrophoresis with electrochemiluminescence detection". Electroanalysis: An International Journal Devoted to Fundamental and Practical Aspects of Electroanalysis, 14(22), 1571-1576, 2002.
https://doi.org/10.1002/1521-4109(200211)14:22<1571::AID-ELAN1571>3.0.CO;2-X
[25] S. El-Saharty, M. Refaat, Z. El-Khateeb, "Simultaneous determination of diclofenac sodium and diflunisal". Bull Fac Pharm Cairo Univ, 40, 47-64, 2002.
[26] A. Gottschalk, N. Raja, "Severing the Link between Acute and Chronic PainThe Anesthesiologist's Role in Preventive Medicine". Anesthesiology: The Journal of the American Society of Anesthesiologists, 101(5), 1063-1065, 2004.
https://doi.org/10.1097/00000542-200411000-00004
[27] J. Pavlin, C. Chen, A. Penaloza, L. Polissar, P. Buckley, "Pain as a factor complicating recovery and discharge after ambulatory surgery". Anesthesia & Analgesia, 95(3), 627-634, 2002.
https://doi.org/10.1097/00000539-200209000-00025
[28] L. Apfelbaum, C. Chen, S. Mehta, J. Gan, "Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged". Anesthesia & Analgesia, 97(2), 534-540, 2003.
https://doi.org/10.1213/01.ANE.0000068822.10113.9E
[29] L. Vigneault, F. Turgeon, D. Côté, F. Lauzier, R. Zarychanski, L. Moore, A. Fergusson, "Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials". Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 58(1), 22-37, 2011.
https://doi.org/10.1007/s12630-010-9407-0
[30] R. Khoshayand, H. Abdollahi, A. Ghaffari, M. Shariatpanahi, H. Farzanegan, "Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches". Daru: journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 18(4), 292, 2010.
[31] L. Vigneault, F. Turgeon, D. Côté, F. Lauzier, R. Zarychanski, L. Moore, A. Fergusson, "Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials". Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 58(1), 22-37, 2011.
https://doi.org/10.1007/s12630-010-9407-0
[32] R. Khoshayand, H. Abdollahi, A. Ghaffari, M. Shariatpanahi, H. Farzanegan, "Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches". Daru: journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 18(4), 292, 2010.
[33] U. Gasanov, D. Hughes, M. Hansbro, "Methods for the isolation and identification of Listeria spp. and Listeria monocytogenes: a review". FEMS microbiology reviews, 29(5), 851-875, 2005.
https://doi.org/10.1016/j.femsre.2004.12.002
[34] Bhusal, P., Sharma, M., Harrison, J., Procter, G., Andrews, G., Jones, D.S., Hill, A.G. and Svirskis, D., 2017. Development, validation and application of a stability indicating HPLC method to quantify lidocaine from polyethylene-co-vinyl acetate (EVA) matrices and biological fluids. Journal of chromatographic science, 55(8), pp.832-838.
https://doi.org/10.1093/chromsci/bmx043
[35] Belal, T.S., Bedair, M.M., Gazy, A.A. and Guirguis, K.M., 2015. Validated selective HPLC-DAD method for the simultaneous determination of diclofenac sodium and lidocaine hydrochloride in presence of four of their related substances and potential impurities. Acta Chromatographica, 27(3), pp.477-493.
https://doi.org/10.1556/AChrom.27.2015.3.6
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[1]
M. A. Salih, D. Fattah Aziz, and S. Ibrahim Ali, “Development and Validation of New High Performance Liquid Chromatography Analytical Technique For Separation of Diclofenac Sodium and Lidocaine Hydrochloride From Ampoule Injection”, KJAR, vol. 5, no. 1, pp. 115–127, Jun. 2020, doi: 10.24017/science.2020.1.11.
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08-06-2020
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