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Authors
Affiliations
1 Department of Pharmacy, IEC College of Engineering and Technology, Plot-4, Greater Noida, U. P., IN
2 Ranbaxy Research Laboratories, Sector-18, Plot-20, Gurgaon-122001, Haryana, IN
Source
Asian Journal of Research in Chemistry, Vol 3, No 4 (2010), Pagination: 1058-1061
Abstract
A simple, rapid, specific, accurate and economic reverse phase HPLC method was developed and validated for determination of acetic acid content in hard gelatin capsule shells from animal origin. Acetic acid is a commonly used excipient in gelatin processing technology. Being a Class III solvent as per ICH guidelines it has a permissible daily intake limit. A reverse-phase HPLC method was developed on a 250 mm×4.0 mm, 5 μm L1 column using UV detection at 205 nm. An ortho-phosphoric acid buffer pH 3.8 and Methanol were used as gradient components for elution. The proposed method was able to analyze acetic acid content directly without any reaction and was simple and sensitive.
Keywords
Acetic Acid, Gelatin Shells, HPLC and Residual Solvent.
