Analytical method development and validation for residual solvent of Diltiazem hydrochloride extended release capsule by Gas chromatography
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2013, Vol 2, Issue 4
Abstract
Residual solvents are organic volatile chemicals that are either used or produced during the manufacture of active pharmaceutical ingredients, excipients, and drug products. Organic solvents such as di ethyl ether, N heptane, acetone, methyl acetate, tertiary - butyl alcohol, iso-propyl alcohol, ethanol , toluene, Nbutanol, and n-butyl acetate frequently used in pharmaceutical industry for the manufacturing of drug product Gas Chromatography method for the determination of residual solvent of Diltiazem Hydrochloride Extended Release Capsules for iso-propyl alcoholhas been carried out using this method.this method utilized Perkin Elmer clarus 580 GC Turbomatrix 40 Headspace sampler and DB-624, 30 m x 0.530 mm ID, 3.0 µm column was used with flame ionizationdetector (FID). The GC method for the determination of residual solvent of Diltiazem Hydrochloride Extended Release Capsules was validated. The method was found to be specific, precise, linear, accurate, rugged, robust and suitable for its intended use.
Authors and Affiliations
Raja Sundararajan
Keywords
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