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A Single RP-LC Method for the Determination of Benzalkonium Chloride and Its Potential Impurities in Benzalkonium Chloride Raw Material

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Abstract

A simple and rapid RP-LC method was developed for routine analysis of benzalkonium chloride (BKC) and its impurities in benzalkonium chloride raw material. The method uses a short ACE 3 C8 column (50 × 4.6 mm, 3 μm particle size) and a gradient mobile phase consisting of 0.025% trifluoroacetic acid in water/acetonitrile (90/10, v/v) as mobile phase A, and water/acetonitrile (30/70, v/v) as mobile phase B. The four commonly observed homologues (i.e., C10, C12, C14 and C16) that are present in typical commercial lots of BKC are well separated from each other in less than 21 min. This method has been demonstrated to be able to simultaneously separate and quantitate at parts-per-million levels the three potential impurities (i.e., benzyl alcohol, benzaldehyde and benzyl chloride) in commercial lots of BKC raw material. In addition, this method has the potential to be readily adopted or adapted for determining BKC homologues in a finished drug product; the feasibility of the latter capability is demonstrated through an artificial product solution containing a model API and typical excipients used for liquid formulation drug products.

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References

  1. United States Pharmacopeia 30 (2007), U.S. Pharmacopeia Convention, Rockville, MD, pp 1069–1070, USA

  2. Richards R, Cavill R (1976) J Pharm Sci 65:76–80

    Article  CAS  Google Scholar 

  3. Ding X, Che Y, Zhao H, Pengyan L (2006) Fenxi Ceshi Xuebao 25:63–66

    CAS  Google Scholar 

  4. Labranche LP, Dumont SN, Levesque S, Carrier A (2007) J Pharm Biomed Anal 43:989–993

    Article  CAS  Google Scholar 

  5. Chen Q, Wang X (2005) Zhongguo Yiyao Gongye Zazhi 39:564–566

    Google Scholar 

  6. European Pharmacopeia 6.5 (2009) monograph for benzalkonium chloride solution

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Acknowledgments

The authors would like to thank Ms. Fangzhu Liu for her knowledge on the BKC raw material.

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Authors and Affiliations

  1. Global Quality Services - Analytical Sciences, Schering-Plough Corporation, 1011 Morris Avenue, Union, NJ, 07083, USA

    Marina Santos, Min Li & Abu M. Rustum

Authors
  1. Marina Santos
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  2. Min Li
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  3. Abu M. Rustum
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Correspondence to Min Li.

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Santos, M., Li, M. & Rustum, A.M. A Single RP-LC Method for the Determination of Benzalkonium Chloride and Its Potential Impurities in Benzalkonium Chloride Raw Material. Chroma 71, 499–503 (2010). https://doi.org/10.1365/s10337-009-1458-4

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  • DOI: https://doi.org/10.1365/s10337-009-1458-4

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