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An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum

Published: 2 April 2013
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Abstract

The aim of the present work was to develop a sensitive liquid chromatographic method for the quantitation of pravastatin and diltiazem along with naproxen and meloxicam using ultraviolet detector. The separation of components was achieved on Purospher Star, C18 (5 µm, 25 x 0.46 cm) column using methanol-water (80:20 v/v) as mobile phase and pH adjusted 3.4 with 85% o-phosphoric acid. Related parameters that may influence the enrichment efficiency of speration of drugs such as the kind and volume of elute, sample flow rate, sample pH, and volume of the drug samples were investi-gated. Detection was performed at ambient temperature at 220 nm by pumping the mobile phase at the flow rate 1.0 mL min-1. The experimental results indicated a good linearity (R 2 > 0.9947) over the concentration range of 0.5-20 µg mL-1 for pravastatin, naproxen and meloxicam and 0.75-24 µg mL-1 for diltiazem. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte's chromophore which enhanced sensitivity with linear range 0.25-8.0, 0.5-16, 0.4-12 and 0.2-4.0 µg mL-1 for pravastatin, diltiazem, naproxen and meloxicam respectively. The LOD values shifted down from 33, 70, 50 and 80 ng mL-1 to 15, 42, 20 and 10 ng mL-1 for pravastatin, diltiazem, na-proxen and meloxicam respectively. Validation of the method showed good precision and accuracy for the proposed method. All the results indicated that this procedure could allow the simultaneous determination of these four compounds in API, pharmaceutical formulations and serum at trace levels. The method can be successfully applied for the determination of these drugs in human serum, clinical laboratories and in pharmaceutical formulations without diode array detector and without interference of excipients or endogenous components of serum.

Published in American Journal of Applied Chemistry (Volume 1, Issue 1)
DOI 10.11648/j.ajac.20130101.11
Page(s) 1-8
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

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Copyright © The Author(s), 2013. Published by Science Publishing Group

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Keywords

Pravastatin, Diltiazem, Naproxen, Meloxicam, RP-HPLC, Time Program

References
[1] Y. An, H. Xin, W. Yan, X. Zhou, Exp. Toxicol. Pathol. 2011, 63, 215.
[2] G. Mariucci, E. Taha, M. Tantucci, C. Spaccatini, A. Tozzi, M. V. Ambrosini, Eur. J. Pharmacol. 2011, 660, 381.
[3] J. D. Dietz, S. Du, C. W. Bolten, M. A. Payne, C. Xia, J.R. Blinn, J.W. Funder, X. Hu, Hypertension 2008, 51, 742.
[4] V. Andrisano, P. Hrelia, R. Gotti, A. Leoni, V. Cavrini, J. Pharm. Biomed. Anal. 2001, 25, 589.
[5] L. G Lala, P. M. D'Mello, S. R. Naik, J. Pharm. Biomed. Anal. 2002, 29, 539.
[6] A. G. Gnidec, W. J. Sibbald, H. Cheung, C.A. Metz, J. Appl. Physiol. 1988, 65, 1024.
[7] N. K. S. Khoo, F. P. H. Chan, M. N. Saarloos, P. K. Lala, Clin. Exp. Metastasis. 1992, 10, 239.
[8] T. P Kennedy, N. V Rao, W. Noah, J. R. Michael, J. M. H. Jafri, G. H. Gurtner, J. R. Hoidal, J. Clin. Invest. 1990, 86, 1565.
[9] K. Kircali, M. Tuncel, H. Y. Aboul-Enein, IL Farmaco. 2004, 59, 241.
[10] S. Ashour, H. Nakshbandi, S. Omar, Int. J. Biomed. Sci. 2008, 4, 135.
[11] K. Cai, B. Tan, Z. Feng, Z. Li, M. Huang, X. Zhao, Chin. J. Chromatogr. 1996, 14, 121.
[12] B. G. Chaudhari, N. M. Patel, P. B. Shah, Indian. J. Pharm. Sci. 2007, 69, 130.
[13] I. A. Darwish, A. R. M. Al-Obaid, H. A. Al-Malaq, Talanta. 2009, 79, 1478.
[14] M. M. Ayad, A. Shalaby, H. E. Abdellatef, M. M. Hosny, Anal. Bioanal. Chem. 2003, 376, 710.
[15] R. I. L. Catarino, A. C. L. Conceição, M. B. Q. Garcia, M. L. S. Goncalves, J. L. F. C. Lima, M. M. Correia dos Santos, J. Pharm. Biomed. Anal. 2003, 33, 571.
[16] N. Sultana, M.S. Arayne, N. Shafi, Pak. J. Pharm. Sci. 2007, 20, 279.
[17] P. V. Devarajan, V. V. Dhavse, J. Chromatogr. B: Biomed. Appl. 1998, 706, 362.
[18] O. Grech-Belanger, E. Leboeuf, S. Langlois, J. Chromatogr. B: Biomed. Appl. 1987, 417, 89.
[19] M. A. Sanchez, F. R. P. Rocha, Anal. Chim. Acta. 2011, 694, 95.
[20] T. M. Phillips, E. F. Wellner, Biomed. Chromatogr. 2006, 20, 662.
[21] A. Aresta, F. Palmisano, C. G. Zambonin, J. Pharm. Biomed. Anal. 2005, 39, 643.
[22] M. H. Guermouche, N. Atik, H. Chader, J. AOAC Int. 2002, 83, 1489.
[23] I. R. Miksa, M. R. Cummings, R. H. Poppenga, J. Anal. Toxicol. 2005, 29, 95.
[24] N. E. Larsen, K. Marinelli, J. Chromatogr. B: Biomed. Appl. 1981, 222, 482.
[25] E. A. Taha, N. N. Salama, L. E. S. A. Fattah, Chem. Pharm. Bull. 1981, 54, 653.
[26] A. E. Radi, M. Ghoneim, A. Beltagi, Chem. Pharm. Bull. 2001, 49, 1257.
[27] E. M. Hassan, J. Pharm. Biomed. Anal. 2002, 27, 771.
[28] W. R. G. Baeyens, G. Van der Weken, E. D’haeninck, A. M. Garcia-Campana, T. Vankeirsbilck, A. Vercauteren, P. Deprez, J. Pharm. Biomed. Anal. 2003, 32, 839.
[29] S. E. Vignaduzzo, P. M. Castellano, T. S. Kaufman, J. Pharm. Biomed. Anal. 2008, 46, 219.
[30] Y. H. Hsieh, S. J. Lin, S. H. Chen, J. Sep. Sci. 2006, 29, 1009.
[31] N. Sultana, M. S. Arayne, S. N. Ali, M. H. Zuberi, Med. Chem. Res. 2012, 21, 2443.
[32] M. S. Arayne, N. Sultana, A. Tabassum, S. N. Ali, S. Naveed, Med. Chem. Res. 2012, 21, 4542.
[33] M. S. Arayne, N. Sultana, S. N. Ali, Amer. J. Anal. Chem. 2013, 4, 24.
[34] N. Sultana, M. S. Arayne, W. Shahzad, J. Chil. Chem. Soc. 2010, 55, 193.
[35] N. Sultana, M. S. Arayne, N. Safila, Chin. J. Chem. 2011, 29, 1216.
[36] N. Sultana, M. S. Arayne, R. Siddique, N. Safila, Amer. J. Anal. Chem. 2012, 3, 147.
[37] N. Sultana, M. S. Arayne, S. N. Ali, Anal. Bioanal. Techniques. 2013, 3, 154.
[38] M. S. Arayne, N. Sultana, A. Tabassum, Res. Rep. Med. Chem. 2012, 2, 19.
[39] N. Sultana, M. S. Arayne, N. Safila, F. A. Siddiqui, Chromatographia. 2010, 71, 71.
[40] M. S. Arayne, N. Sultana, F. A. Siddiqui, Pak. J. Pharm. Sci. 2005, 18, 58.
[41] N. Sultana, M. S. Arayne, B. Iftikhar, J. Chin. Chem. Soc. 2008, 5, 1022.
[42] International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Validation of Analytical Procedure: Text and Methodology Q2 (R1) Complimentary Guideline on Methodology Dated 06 Nov 1996, Incorporated in Nov 2005, London.
[43] D. A. Armbruster, M. D. Tillman, L. M. Hubbs, Clin. J. Chem. 1994, 40, 1233.
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    Najma Sultana, Muhammad Saeed Arayne, Saeeda Nadir Ali. (2013). An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum. American Journal of Applied Chemistry, 1(1), 1-8. https://doi.org/10.11648/j.ajac.20130101.11

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    ACS Style

    Najma Sultana; Muhammad Saeed Arayne; Saeeda Nadir Ali. An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum. Am. J. Appl. Chem. 2013, 1(1), 1-8. doi: 10.11648/j.ajac.20130101.11

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    AMA Style

    Najma Sultana, Muhammad Saeed Arayne, Saeeda Nadir Ali. An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum. Am J Appl Chem. 2013;1(1):1-8. doi: 10.11648/j.ajac.20130101.11

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  • @article{10.11648/j.ajac.20130101.11,
      author = {Najma Sultana and Muhammad Saeed Arayne and Saeeda Nadir Ali},
      title = {An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum},
      journal = {American Journal of Applied Chemistry},
      volume = {1},
      number = {1},
      pages = {1-8},
      doi = {10.11648/j.ajac.20130101.11},
      url = {https://doi.org/10.11648/j.ajac.20130101.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajac.20130101.11},
      abstract = {The aim of the present work was to develop a sensitive liquid chromatographic method for the quantitation of pravastatin and diltiazem along with naproxen and meloxicam using ultraviolet detector. The separation of components was achieved on Purospher Star, C18 (5 µm, 25 x 0.46 cm) column using methanol-water (80:20 v/v) as mobile phase and pH adjusted 3.4 with 85% o-phosphoric acid. Related parameters that may influence the enrichment efficiency of speration of drugs  such as the kind and volume of elute, sample flow rate, sample pH, and volume of the drug  samples were investi-gated. Detection was performed at ambient temperature at 220 nm by pumping the mobile phase at the flow rate 1.0 mL min-1. The experimental results indicated a good linearity (R 2 > 0.9947) over the concentration range of 0.5-20 µg mL-1 for pravastatin, naproxen and meloxicam and 0.75-24 µg mL-1 for diltiazem. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte's chromophore which enhanced sensitivity with linear range 0.25-8.0, 0.5-16, 0.4-12 and 0.2-4.0 µg mL-1 for pravastatin, diltiazem, naproxen and meloxicam respectively. The LOD values shifted down from 33, 70, 50 and 80 ng mL-1 to 15, 42, 20 and 10 ng mL-1 for pravastatin, diltiazem, na-proxen and meloxicam respectively. Validation of the method showed good precision and accuracy for the proposed method. All the results indicated that this procedure could allow the simultaneous determination of these four compounds in API, pharmaceutical formulations and serum at trace levels. The method can be successfully applied for the determination of these drugs in human serum, clinical laboratories and in pharmaceutical formulations without diode array detector and without interference of excipients or endogenous components of serum.},
     year = {2013}
    }
    

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  • TY  - JOUR
    T1  - An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum
    AU  - Najma Sultana
    AU  - Muhammad Saeed Arayne
    AU  - Saeeda Nadir Ali
    Y1  - 2013/04/02
    PY  - 2013
    N1  - https://doi.org/10.11648/j.ajac.20130101.11
    DO  - 10.11648/j.ajac.20130101.11
    T2  - American Journal of Applied Chemistry
    JF  - American Journal of Applied Chemistry
    JO  - American Journal of Applied Chemistry
    SP  - 1
    EP  - 8
    PB  - Science Publishing Group
    SN  - 2330-8745
    UR  - https://doi.org/10.11648/j.ajac.20130101.11
    AB  - The aim of the present work was to develop a sensitive liquid chromatographic method for the quantitation of pravastatin and diltiazem along with naproxen and meloxicam using ultraviolet detector. The separation of components was achieved on Purospher Star, C18 (5 µm, 25 x 0.46 cm) column using methanol-water (80:20 v/v) as mobile phase and pH adjusted 3.4 with 85% o-phosphoric acid. Related parameters that may influence the enrichment efficiency of speration of drugs  such as the kind and volume of elute, sample flow rate, sample pH, and volume of the drug  samples were investi-gated. Detection was performed at ambient temperature at 220 nm by pumping the mobile phase at the flow rate 1.0 mL min-1. The experimental results indicated a good linearity (R 2 > 0.9947) over the concentration range of 0.5-20 µg mL-1 for pravastatin, naproxen and meloxicam and 0.75-24 µg mL-1 for diltiazem. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte's chromophore which enhanced sensitivity with linear range 0.25-8.0, 0.5-16, 0.4-12 and 0.2-4.0 µg mL-1 for pravastatin, diltiazem, naproxen and meloxicam respectively. The LOD values shifted down from 33, 70, 50 and 80 ng mL-1 to 15, 42, 20 and 10 ng mL-1 for pravastatin, diltiazem, na-proxen and meloxicam respectively. Validation of the method showed good precision and accuracy for the proposed method. All the results indicated that this procedure could allow the simultaneous determination of these four compounds in API, pharmaceutical formulations and serum at trace levels. The method can be successfully applied for the determination of these drugs in human serum, clinical laboratories and in pharmaceutical formulations without diode array detector and without interference of excipients or endogenous components of serum.
    VL  - 1
    IS  - 1
    ER  - 

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Author Information
  • Department of Pharmaceutical Chemistry, University of Karachi, Karachi-75270, Pakistan

  • Department of Chemistry, University of Karachi, Karachi-75270, Pakistan

  • Department of Chemistry, University of Karachi, Karachi-75270, Pakistan

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