Development and Validation of an HPLC Assay For Dual Detection of Gentamicin Sulfate and Leucine From a Novel Dry Powder For Inhalation
- *Corresponding Author:
- Philip J. Kuehl
Lovelace Respiratory Research Institute
2425 Ridgecrest Dr. SE, Albuquerque
NM 87108, USA
E-mail: [email protected]
Received date: October 30, 2012; Accepted date: November 23, 2012; Published date: November 26, 2012
Citation: Kuehl PJ, De S, Eppler B, Marsters J, Matthews L, et al. (2012) Development and Validation of an HPLC Assay For Dual Detection of Gentamicin Sulfate and Leucine From a Novel Dry Powder For Inhalation. J Anal Bioanal Tech 3:152. doi: 10.4172/2155-9872.1000152
Copyright: © 2012 Kuehl PJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.