Validated Reverse Phase HPLC Method for the Determination of Acetic Acid Content in Hard Gelatin Capsule Shells from Animal Origin

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.