Comparative Bioavailability Study of Amisulpride Tablets in Healthy Indian Volunteers

Abstract

An improved HPLC method was developed and validated for the determination of concentration of amisulpride (CAS 71675-85-9) in human plasma, an attempt to compare the bioavailability of two amisulpride tablet formulations (reference and test) containing 200 mg of amisulpride. Both the formulations were administered orally as a single dose, separated by washout period of 1 week. This HPLC method validated by examining the precision and accuracy for the inter-day and intra-day runs in a linear concentration range of 50– 1200 ng/ml. Bioequivalence of two formulation were determined on 12 healthy Indian male volunteer in a single-dose, two-period, two-sequence, two-treatment crossover study. The content of amisulpride in plasma was determined by a validated HPLC method with UV detection. The formulations were compared using the parameters like area under the plasma concentration-time curve (AUC_0–t), area under the plasma concentration-time curve from zero to infinity (AUC_0–∞), peak plasma concentration (C_max), and time to reach peak plasma concentration (t_max). The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmic transformed AUC_0–∞ and C_max values, between test and reference formulation. The 90% confidence interval for the ratio of the logarithmic transformed AUC_0–t, AUC_0–∞ and C_max were within the bioequivalence limit of 0.8–1.25 and the relative bioavailability of test formulation was 96.82% to that of reference formulation.

Key words

Amisulpride, bioequivalence, HPLC UV detection, pharmacokinetics - Antipsychotics - CAS 71675-85-9

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