A RESEARCH ON: DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR ESTIMATION OF PRESERVATIVES IN PHARMACEUTICAL FORMULATION BY AQBD APPROACH

Pharmaceutical Chemistry, Biotechnology, Medicinal Chemistry

An accurate, simple, rapid and sensitive high performance thin layer chromatographic (HPTLC) method for the determination of paracetamol, Methyl paraben and Propyl paraben was developed and validated in the bulk drug and tablet dosage form by AQbD Approach. Aluminum foil precoated Silica gel G 60F254 plates were used as stationary phase and Toluene: Ethyl acetate: Glacial acetic acid (6.5:2.5:0.5) as mobile phase. Wavelength selected for analysis was 254 nm. The one drug and preservatives were satisfactorily resolved with Rf 0.45± 0.02 for Paracetamol, Rf 0.75 ± 0.05 for Methyl paraben and Rf 0.92 ± 0.05 for Propyl paraben. The method was validated according to ICH guidelines. Linearity was found to be in the concentration range of 100–600 ng/band for Paracetamol and 1-60 ng/band for Methyl paraben and Propyl paraben, respectively. The mean recovery of Paracetamol, Methyl paraben and Propyl paraben was found to be 99.74, 99.56 and 99.51 respectively. Developed HPTLC method was found to be accurate, precise, selective and rapid for simultaneous estimation of Paracetamol, Methyl paraben and Propyl paraben. Thus, it can be used for routine quality control of paracetamol, Methyl paraben and Propyl paraben in various dosage forms.

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.