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New Assay Methods for Tetracycline Drug Products

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Application Note 288: New HPLC and UHPLC Assay Methods for Tetracycline Hydrochloride and 4-Epianhydrotetracycline Hydrochloride Impurity in Tetracycline Drug Products demonstrates that the results from both methods meet or exceed the criteria in the appropriate United States Pharmacopeia (USP) monographs. Both methods are faster and show higher resolution than the current methods. They also generate less waste and use less hazardous organic solvents. These methods may be applicable to other TC-HCl-containing drug products.

These new assay methods use Thermo Scientific Acclaim™ Polar Advantage II (PA2) reversed-phase columns. The HPLC method uses a 4.6 × 150 mm column packed with a 3 μm resin and an acetonitrile/ammonium dihydrogen orthophosphate pH 2.2 mobile phase. The Acclaim PA2 column is made with high-purity spherical silica and—unlike a standard C8 column—can be used in a pH range of 1.5–10.