Prior to the August 1, 2013 release of the first supplement to USP 36 � NF 31, the determination of Gentamicin content in Gentamicin Sulfate, as directed by the United States Pharmacopoeia (USP) employed HPLC with pre-column functionalization with ortho-phthalaldehyde and detection at 330nm.  Upon the release of the first supplement, the determination of content of Gentamicins shifts to an HPLC method employing pulsed amperometric electrochemical detection (PAD) and post-column reaction with sodium hydroxide.  This talk will detail the validation of a method for use in routine cGMP analysis of USP Gentamicin Sulfate, employing the BASi LC Epsilon Amperometric Detector, and will highlight the advantages of PAD as a detection technique for content of Gentamicins.  In addition to method details, the installation and validation of the detector onto an existing HPLC system will also be discussed.

Revised chromatographic determination of Gentamicin content in conformity with the August revision of the USP

246th National Meeting (2013)

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