Hepatoprotective Activity of Hydroalcoholic and Ethyl Acetate Extract of Abutilon indicum Leaf on Rats”

摘要

Residual solvents are used in the manufacturing of active pharmaceutical ingredients, excipients and film coating. These are toxic substances and not desirable in the final product because residual solvents effect the quality and stability of the drug. As the residual solvents cannot be removed completely, they should be within the acceptance limits published in regulatory guidelines such as ICH guidelines (Q3C). GCHS is the most commonly used technique for analysis of volatile solvents. So the aim of the present work is to develop a simple, specific GC-HS method for the determination of residual solvents in famotidine using nitrogen as the carrier gas at the rate of 2.5 ml/min with ZB-624 (30m × 0.53mm, 0.5μ) as column using FID as detector. The developed method was validated as per ICH guidelines and all the parameters are found to be within the limits.