ABSTRACT
In the present study, two brands of Kumaryasava and Mustakarista medicinally important ayurvedic preparations were studied for quality control parameters like physiochemical properties, ethanol content by specific gravity and gas chromatographic methods and the total phenolic content. Evaluation of physiochemical properties and total phenolic contents resulted in establishing ranges for routine analysis. In both the formulations, ethanol content observed by specific gravity method varied from 0.9 to 1.9% on day 0 and reduced on storage for 30 days ranging from 0.1-0.6% v/v. Similarly, ethanol content determined by GC on day 0 varied from 0.1-1.6% v/v and on 30th day from 0.011-0.025% v/v. This reduction in ethanol content on storage might be due to loss caused by frequent opening of the container.
ABSTRACT
The bioequivalence of two oral formulations containing aceclofenac 100 mg was determined in 24 healthy Indian male volunteers. The study was designed as a single dose, fasting, two-period two-sequence crossover study with a washout period of 1 week. The content of aceclofenac in plasma was determined by a validated HPLC method with UV detection. The preparations were compared using the parameters 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). No statistically significant difference was observed between the logarithmic transformed AUC0-infinity and Cmax values of the two preparations. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-t, AUC0-infinity, and Cmax were within the bioequivalence limit of 0.80-1.25.
