+44 1625708989Development and Evaluation of 1, 3 Dibromo Propane as a Genotoxic Impurity in Olopatadine Hydrochloride Drug Substance by Using HSGC
Author(s): Vinayak T. Vele*, Krupali Shah, Vishal Telvekar, Rupesh Kelaskar and Mohan A ChandavarkarA simple and accurate gas chromatography head space method was developed for the determination of 1, 3 Dibromo Propane in the Olopatadine Hydrochloride bulk drug. Chromatographic separation between 1, 3 Dibromo Propane, diluent and residual solvents used in Olopatadine Hydrochloride was achieved using a DB-624 (30 m x 0.53 mm x 3.0 μm) column using nitrogen as carrier gas. The resolution between the between 1, 3 Dibromo Propane and Benzyl alcohol as diluent was found to be more than 5.0. The Limit of Detection (LOD) and limit of quantification (LOQ) of the 1, 3 Dibromo Propane was 1.46 and 4.37 μg mL-1, respectively. The percentage recoveries of the 1, 3 Dibromo Propane ranged from 95.1% to 111.5 in the samples of Olopatadine Hydrochloride. The developed method was validated as per International Conference on Harmonization guidelines in terms of specificity, limit of detection, limit of quantification, precision, linearity, accuracy and ruggedness.
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