A Novel Validated Gas Chromatography Headspace (GC-HS) Method for the Simultaneous Quantification of Six Organic Volatile Impurities in Biperiden HCL Pure and Pharmaceutical Dosage Forms
Keywords: 1,4-Dioxane, Benzene, Biperiden HCl API, Di-isopropyl ether, Isopropyl alcohol, Methanol, Method development and Validation, Tetrahydrofuran.
AbstractA novel, simple, and sensitive Gas Chromatography Headspace method for simultaneous quantification of six organic-volatile impurities in Biperiden HCL API and its pharmaceutical dosage forms using ZB-624 30 m × 0.53 mm, 3.0 μ column with Flame Ionized detector at 250°C. The Injector temperature is maintained at 225°C. The nitrogen gas was used as a carrier gas with a 3.0 mL/min flow rate. The method involved a thermal gradient elution. The total run time is 25.0 minutes. The method was linear over the concentration range of the limit of quantification to 150% of each impurity. The limit of quantification was found 57 ppm for Methanol, 107 ppm for Isopropyl alcohol, 143 ppm for Di-isopropyl ether, 19.5 ppm for Tetrahydrofuran, 0.1 ppm for Benzene, and 14.6 ppm for 1,4-Dioxane. The calculated recoveries were obtained should be 85-115%. Furthermore, verified precision, ruggedness, robustness, Solution stability, and pharmaceutical analysis were done. All the results are found within acceptable limits. The suggested GC-HS method can quantify six organic-volatile impurities in Biperiden HCl API and its pharmaceutical dosage forms.
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