Anti-microbial lead compound Sulfonamide - Anthranilate derivative Methyl-Ester-Toluene-Sulfonamide and its purity by Liquid Chromatography to develop the New Drug Application.

The newly innovated and synthesized lead molecule Methyl-Ester-Toluene-Sulfonamide is the combined derivative of sulphonamide-anthranilate. The estimation was achieved by gradient elution using mobile phase 0.1% Triethylamine in water and with pH 2.0 as mobile phase A and mixture of acetonitrile and tetrahydrofuran in the ratio of (975:25) v/v as mobile phase B at 0.8 mL min flow rate and 210 nm wavelength on Agilent 1260 infinity series HPLC system equipped with DAD detector. The column used was ACE 3 C18 PFP (250 mm × 4.6 mm) 3 μm column operating at 40 °C temperature. The gradient programme is time (min)/% B: 0.0/50, 3.0/50, 15.0/70, 25.0/90, 30.0/90, 31/50, & 38/50. The method is simple, accurate, rapid and selective. The method was found linear with concentration range of 1.6 to 240 μg/mL. The accuracy data obtained from 98.5 % to 100.5 %. The method validation data and QbD-based robustness study results indicate that the developed method is robust and fit for routine use in the quality control laboratory. Therefore, the ready availability of method can be useful in pharmaceutical new drug development.