A new RP-HPLC method was developed for the quantitative determination of acamprosate calcium in human plasma as per US-FDA guidelines. The drug was spiked in the plasma and extracted with the acetonitrile by the precipitation method. The extracted analyte was injected in to a Symmetry C18 (4.6 x 150 mm, 5 µm, Make: Primesil), maintained at 25°C and the effluent was monitored at 215 nm. The mobile phase consisted of acetonitrile:potassium dihydrogen phosphate pH 3.0 (80:20 V/V). The flow rate was maintained at 1.0 ml min-1. The calibration curve for acamprosate calcium was linear from 0.5 to 2.5 µg ml-1 (r2 0.997) and the retention time was 2.2 min. The inter-day and intra-day precision was found to be within the limits. The LOD and LOQ were found to be 0.049 and 0.15 µg ml-1 respectively. The average % recovery was 98.9-101.6 % and the reproducibility was found to be satisfactory and within acceptable range. The proposed method has an adequate sensitivity, reproducibility and specificity for determination of acamprosate acalcium in bulk and pharmaceutical individual dosage forms in human plasma and the method can be applied to monitor plasma concentration of acamprosate calcium in pharmacokinetic studies.
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