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LC Determination and Stability Assessment of Macrolide Antibiotics Azithromycin and Spiramycin in Bulk and Tablet Samples

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Abstract:

Development and validation of rapid HPLC method for quantifying macrolide antibiotics azithromycin (AZI) and spiramycin (SPI) in bulk and tablet samples is described. Determination was performed on a reversed phase C18 ODB column (250×4.6 nm I.D) at ambient temperature, and employing a UV-detection set at 210 nm. The mobile phase consists of acetonitrile –2-methyl-2-propanol–hydrogenphosphate buffer, pH 6.2, with 1.8% triethylamine (32:8: up to 100, v/v/v), delivered at a flow-rate of 1.1 mL min-1. The assay is linear in concentration ranges of: 0.004–4.8 and 0.0003–1.2 mg mL−1 for azithromycin and spiramycin, respectively, with detection limit of 0.02% for SPI and 0.03% for AZI. Recovery experiments revealed recovery of 98.51–100.82%. The applicability of this method in stability assessment studies is evaluated.

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Periodical:
International Letters of Natural Sciences (Volume 47)
Pages:
1-10
Citation:
A. Mahmoudi "LC Determination and Stability Assessment of Macrolide Antibiotics Azithromycin and Spiramycin in Bulk and Tablet Samples", International Letters of Natural Sciences, Vol. 47, pp. 1-10, 2015
Online since:
September 2015
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[1] J. Elks, C.R. Ganellin (Eds. ), Dictionary of Drugs, Chapman and Hall, London, (1991).

[2] S. Omura (Ed. ), Macrolide Antibiotics: Chemistry, Biology and Practice, Academic Press, Orlando, FL, (1984).

[3] A. Mahmoudi, R.E. -A. Fourar, M.S. Boukhechem, S. Zarkout, Int. J. Pharm. 491 (2015) 285–291.

[4] L.C. Vaucher, C.S. Paim, A.D. Lange, E.E.S. Schapoval, Int. J. Pharm. 366 (2009) 82–87.

[5] C. Stubbs, I. Kanfer, Int. J. Pharm. 63 (1990) 113–119.

[6] O. Farghaly, N. Mohamed, Talanta 62 (2004) 531–538.

[7] C. Boyer, K. Gaudin, T. Kauss, A. Gaubert, A. Boudis, J. Verschelden, M. Franc, J. Roussille, J. Boucher, P. Olliaro, N.J. White, P. Millet, J-P. Dubost, J. Pharm. Biomed. Anal. 67– 68 (2012) 10–15.

DOI: https://doi.org/10.1016/j.jpba.2012.04.009

[8] S. Ashour, R. Bayram, Spectrochim Acta Part A: Mol. Biomol. Spectrosc. 99 (2012) 74–80.

[9] P.Y. Khashaba, J. Pharm. Biomed. Anal. 27 (2002) 923–932.

[10] A.P. Kumar, J.H. Park, J. Chromatogr. A. 1218 (2011) 1314–1317.

[11] H.K. Chepkwony, A. Vermaelen, E. Roets, J. Hoogmartens. Chromatographia 54 (2001) 51–56.

[12] N. Furusawa, Talanta. 49 (1999) 461–465.

[13] Z.Y. Yang, L. Wang, X. Tang, J. Pharm. Biomed. Anal. 49 (2009) 811–815.

[14] F.N. Kamau, H.K. Chepkwony, J.K. Ngugi, E. Roets, J. Hoogmartens, J. Chromatogr. Sci. 40 (2002) 529–533.

[15] C. Leal, R. Codony, R. Compañó, M. Granados, M. D. Prat, J. Chromatogr. A. 910 (2001) 285 –290.

[16] M.J. González de la Huebra, U. Vincent, C. von Holst, J. Pharm. Biomed. Anal. 43 (2007) 1628–1637.

[17] E. Wilms, H. Trumpie, W. Veenendaal, D. Touwa, J. Chromatogr. B. 814 (2005) 37–42.

[18] G. Bahrami, S. Mirzae, A. Kiani, J. Chromatogr. B. 820 (2005) 277–281.

[19] M.J. González de la Huebra, U. Vincent, G. Bordin, A.R. Rodríguez, Anal. Chim. Acta. 503 (2004) 247–256.

[20] M. Horie, H. Takegami, K. Toya, H. Nakazawa, Anal. Chim. Acta. 492 (2003) 187–197.

[21] R.V.S. Nirogi, V.N. Kandikere, M. Shukla, K. Mudigonda, S. Maurya, R. Boosi, A. Yerramilli, Anal. Chim. Acta. 553 (2005) 1–8.

[22] Y. Shen, C. Yin, M. Su, J. Tu, J. Pharm. Biomed. Anal. 52 (2010) 99–104.

[23] R.V. Nirogi, V.N. Kandikere, M. Shukla, K. Mudigonda, S. Maurya, R. Boosi, A. Yerramilli, Anal. Chim. Acta 553 (2005) 1–8.

[24] United States Pharmacopoeia 32ed, United States Pharmacopeial Convention, Rockville, MD, 2009, p.2292.

[25] British Pharmacopoeia, fifth ed., Her Majesty's Stationery Office Ltd., London, (2011).

[26] International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, (2005).

[27] P. Hubert, J.J. Ngyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, Validation des procédures analytiques quantitatives: Harmonisation des démarches, STP. Pharma Pratiques. 13 (2003).

DOI: https://doi.org/10.1016/j.jpba.2004.07.027
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