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Development and Validation of an HPLC Assay For Dual Detection of Gentamicin Sulfate and Leucine From a Novel Dry Powder For Inhalation

Philip J Kuehl, Samiran De, Barbel Eppler, Jane Marsters, Laura Matthews, Matthew D Reed and James D Talton

A stability indicating HPLC assay with UV detection was developed for the simultaneous quantification of Gentamicin Sulfate and L-leucine from NanoGENT™ dry powder for inhalation. In order to support the development of the NanoGENT™ (dry powder gentamicin sulfate for inhalation) the assay was created to allow simultaneous detection of the active pharmaceutical ingredient (gentamicin sulfte) and the primary excipient (L-leucine). In order to quantify Gentamicin Sulfate by UV detection derivatization was required. The assay resolved L-leucine from all four Gentamicin Sulfate peaks and all four Gentamicin Sulfate peaks from each other with a reversed phase isocratic assay. Once developed the assay was validated in accordance with regulatory guidance in order to support regulatory approval of the NanoGENT™ dry powder inhalation formulation. The validation data indicated that the dual detection assay meets or exceeded all criteria for use as a stability indicating assay.