A combined Qualitative and Quantitative method development and validation of vancomycin hydrochloride injection formulation by HPLC and UV involving Quality by Design.

Abstract

The selective, specific, precise, linear, accurate, and robust analytical method was developed and validated for the assay of Vancomycin HCl in Vancomycin Hydrochloride Injection. Comparative UV spectrophotometric and reverse phase HPLC developed the quantitative determination. Acetonitrile and pH 2.2 phosphate buffer in the ratio (20:80 v/v) used as mobile phase, and flow rate 1.0 mL/min with 20 mins run time. The detection was carried out at 235 nm with Nucleosil C18 (250 mm × 4.6 mm) 10 μm column, and the ambient column temperature was maintained. The method uses the 20 μL injection volume and diluent as a blank solution in this connection. The method was validated as per the current regulatory guidelines. The linearity of this method was found to be linear in the range of 50% to 150% of the working concentration, and the correlation coefficient was more than 0.999. The method's accuracy was within the acceptable range, which was found to be 98.1 % to 101.5 %. The method's precision was within an acceptable range of about % RSD of 0.32 %. The analytical solution was found stable for up to 48 hrs at room temperature. The method's robustness was proved by utilizing quality design tools. Stress studies demonstrated method stability indicating nature.