1Department of Pharmacy, IEC College of Engineering and Technology, Plot -4, Greater Noida, Uttar Pradesh, India
2Ranbaxy Research Laboratories, Sector-18, Plot-20, Gurgaon, Haryana-122001, INDIA
*Corresponding Author E-mail: vandanadhillon@gmail.com
Online published on 13 March, 2013.
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 x 4.0 mm, 5μm 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.
Acetic acid, Gelatin shells, HPLC and Residual solvent
