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Validation of RP-HPLC method for the determination of phenytoin sodium residues on the surface of manufacturing equipments and study of its recovery from pharmaceutical formulations | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
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Abstract

Validation of RP-HPLC method for the determination of phenytoin sodium residues on the surface of manufacturing equipments and study of its recovery from pharmaceutical formulations

Author(s): Shashikant B. Bagade*, Shirish S. Deshpande and Dixit A. Shah

Cleaning validation provides assurance to the cleaning procedure that ensures equipment is consistently cleaned from the product, detergent and microbial residues to an acceptable level to avoid contamination and cross contamination. In the pharmaceutical manufacturing it is an important step consists in the removal of possible drug residues from the equipments and areas. The cleaning procedures must be validated and methods to determine trace amounts of drugs. An RP-HPLC method for the determination of phenytoin sodium residues on equipment surfaces was developed and validated in order to control a cleaning procedure. Cotton swabs, moistened with methanol were used to remove any residues of drugs from surfaces. And recovery study conducted for the tablet and injection at three concentration levels of 80, 100 and 120 %. The precision of the results, reported as the relative standard deviation (RSD), were below 3.2 %. The method was validated over a concentration range of 2-10μg mL-1. Low quantities of drug residues were determined by HPLC using a Kromasil® C18 column (100×4.6mm, 5μm) at 20 °C with phosphate buffer pH 3.5±0.05 as mobile phase at a flow rate of 1.0 mL min1, an injection volume of 20 μL and were detected at 254 nm using UV detector. A simple, selective and sensitive HPLC assay for the determination of phenytoin sodium residues on equipment surface was developed, validated and applied. The analysis of variance (ANOVA) is applied to find change occurred, if any while recovery study using two different formulations (using Graphpad Prism Ver. 5.0).


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