Abstract
A liquid chromatography-thermospray tandem mass spectrometric (LC-MS-MS) method was developed to determine the presence of clavam-2-carboxylate in clavulanate potassium at below the 0.01% level stated in the US Pharmacopeia (USP). The USP method is for bulk chemical but it was hoped to extend the determination to formulated products. The method described here Involves selected reaction monitoring of m/z 156 giving rise to m/z 114, using negative ion thermospray ionisation. The selected reaction monitoring method was highly specific for clavam-2-carboxylate and was capable of detecting clavam-2-carboxylate in clavulanate potassium at levels of 0.001% ( w w ), an order of magnitude better than the sensitivity required by the USP.
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