Development And Validation Of An Analytical Method For Estimating Residual Solvents In Amlodipine Using Headspace Gas Chromatography

Abstract

Organic volatile contaminants and Residual impurities present in pharmaceutical products are estimated by using Head Space Gas Chromatography. In this study a Head Space Gas Chromatography method was used to detect residual solvents and organic volatile contaminants present in Amlodipine tablet dosage form. Amlodipine is a well-established, extended-release calcium channel blocker (CCB) known for its efficacy in reducing blood pressure. In this study an attempt was made to analyze the residual organic solvents such as Methanol and Ethanol present in Amlodipine tablet dosage form by headspace gas chromatography (HS-GC). The carrier gas streamed was nitrogen, the method was developed and optimized by using HP-InnoWax Column (30 m × 320 µm × 0.5 µm) coated with Polyethylene Glycol as stationary phase and coupled with flame ionization detector. An injector temperature of 250°C was programmed to prevent degradation. A temperature of 40°C was set as the initial oven temperature and monitored at a final temperature of 125°C. N, N-dimethylacetamide was selected as the sample solvent. The validation studies were performed with regard to International Council for Harmonization (ICH) Q2 guidelines for validation of analytical experiments. All the validation parameters complied with the specification limit. Hence, the optimized method developed and validated can be utilized for the concurrent detection of residual solvents in tablet formulations.