Research Article
Development and Validation of an HPLC Assay For Dual Detection of Gentamicin Sulfate and Leucine From a Novel Dry Powder For Inhalation
Philip J Kuehl1*, Samiran De3, Barbel Eppler2, Jane Marsters1, Laura Matthews2, Matthew D Reed1 and James D Talton2
1Lovelace Respiratory Research Institute, 2425 Ridgecrest Dr. SE, Albuquerque, NM 87108, USA
2Nanotherapeutics, Inc. 13859 Progress Blvd., Suite 300, Alachua, FL 32615, USA
3NextBreath LLC, 1450 South Rolling Rd., Baltimore, MD, 21227, USA
- *Corresponding Author:
- Philip J. Kuehl
Lovelace Respiratory Research Institute
2425 Ridgecrest Dr. SE, Albuquerque
NM 87108, USA
Tel: 505-348-9745
Fax: 505-348-8567
E-mail: pkuehl@lrri.org
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.
Abstract
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 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.
