A high performance liquid chromatography tandem mass spectrometric simple protein precipitation method for the estimation of Clavulanate potassium (CLV), in human plasma in Negative ion mode was developed and validated by using Sulbactam (SLB) as internal standard (IS). Sample preparation was accomplished by using 250 ?L of human plasma. The reconstituted samples were chromatographed on Zorbax Eclipse XDB C18 150x4.6 mm, 5?m column using a mobile phase consisting of HPLC grade acetonitrile: 5mM ammonium acetate (70:30, v/v). The flow rate was 1.0 mL/min.The method was validated over a concentration range of 25.220 to 8095.123ng/mL. The validation provides the results of selectivity, sensitivity, matrix effect, calibration standards and quality control samples data, precision and accuracy data, recovery, various stabilities, run size evaluation and dilution integrity. Totally five precision and accuracy batches were performed during the entire validation and intra-day and inter-day precision and accuracy were proved. Concomitant drug effect investigated results are within their limits, not compromised with potentially interfering concomitant medication. The method was validated and was suitable for the quantitation of clavulanate from plasma samples in a pharmacokinetic study.
