Abstract
Author(s): Pravin Jadhav, Surekha Jadhav, Kavita Mehra, Harsha Katre, Chhaya Varkhade, Harshal Pawar
Cleaning validation is a Process of providing documented evidence that the cleaning methods employed within a facility consistently controls carryover of product. The aim of the present study was to validate simple analytical method for verification of residual Valsartan in equipment’s used in the production area and to confirm efficiency of cleaning procedure. UV spectrophotometric method was developed and the detection was made at 233 nm. A cleaning verification assay was validated by using rinsing sampling technique. Recovery studies were carried out on stainless steel surface. The calibration curve was linear over a concentration range from 0.1 to 10.0 µg /mL with a correlation coefficient of 0.999. Detection limit and quantitation limit was detected by UV visible spectroscopy as 0.2 and 0.98 µg/mL .The developed UV spectroscopic method can be used successfully for routine analysis of valsartan residues on cleaned surface in production area.
