Comparative bioavailability study of amisulpride tablets in healthy Indian volunteers.
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 (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-infinity), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmic transformed AUC0-infinity and Cmax, values, between test and reference formulation. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-t, AUC0-infinity, and Cmax 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.
Das
Ayan
A
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Bhaumik
Uttam
U
Chakrabarty
Uday S
US
Sarkar
Amlan Kanti
AK
Ghosh
Animesh
A
Bose
Anirbandeep
A
Chatterjee
Bappaditya
B
Pal
Tapan K
TK
D000328:Adult; D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D007194:India; D007202:Indicators and Reagents; D008297:Male; D013056:Spectrophotometry, Ultraviolet; D013469:Sulpiride / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013607:Tablets; D055815:Young Adult
D014150:Antipsychotic Agents; D007202:Indicators and Reagents; D013607:Tablets; D013469:Sulpiride; D000077582:Amisulpride