Eco-friendly RP-HPLC UV Quantification Method for Parental Products Buffer Agents by Utilizing Polymethacrylate Resin Stationary Phase in Light of Quality by Design

Abstract

Parental products buffer agents viz. calcium phosphate (CP), potassium phosphate (PP) and sodium phosphate (SP) were successfully qualitatively and quantitatively determined on RP-HPLC in the UV detection. The three components were retained in reverse phase by utilizing polymethacrylate resin stationary phase. The quantification was done by using the waters IC-Pak (50 × 4.6) mm, 10 μm column with 1.0 mL/min flow rate. 0.1 M nitric acid solution was used as a mobile phase. The detection was done at 288 nm, column temperature was 30 ºC, injection volume was 50 μL and the total run time was 5 min. The method was validated as per the regulatory and ICH guidelines. The accuracy was found from 98.5% to 101.5% and the precision data was found from 0.5% to 0.9%. The linearity resulted in r value more than 0.999. Quality by design software was used to establish the method robustness. Green chemistry principles and tools were used to assess the method eco-ness. The developed method can be utilized as an application to quantify the buffer agent content in selected parental products.