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A validated HPLC method for assay of morphine hydrochloride and hydromorphone hydrochloride in pharmaceutical injections

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Summary

A sensitive and rapid routine HPLC method is proposed for quantitative estimation of morphine hydrochloride and hydromorphone hydrochloride in pharmaceutical dosage forms. The drugs were chromatographed on a C18 reversed-phase column; the mobile phase was acetonitrile-water, 35:65 (v/v), containing sodium dodecyl sulphate (0.5%, w/v), as ion pairing reagent, and acetic acid (0.4% v/v). Detection was at 230 nm.

The optimized method was validated and linearity (r>0.999), precision, and accuracy were found to be acceptable within the concentration ranges 86–124 μg mL−1 for morphine hydroloride and 60–180 μg mL−1 for hydromorphone hydrochloride.

The method is being used to investigate the stability of morphine hydrochloride and hydromorphone hydrochloride in solution used for intramuscular injection.

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Authors and Affiliations

  1. Laboratory of Drug Quality Control, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, 9000, Ghent, Belgium

    E. Smet, G. Van der Weken & W. R. G. Baeyens

  2. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, 9000, Ghent, Belgium

    J. P. Remon

Authors
  1. E. Smet
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  2. G. Van der Weken
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  3. W. R. G. Baeyens
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  4. J. P. Remon
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Smet, E., Van der Weken, G., Baeyens, W.R.G. et al. A validated HPLC method for assay of morphine hydrochloride and hydromorphone hydrochloride in pharmaceutical injections. Chromatographia 53, 35–39 (2001). https://doi.org/10.1007/BF02492424

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  • DOI: https://doi.org/10.1007/BF02492424

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