Sensitive and Robust RP-HPLC Method for Determination of Valethamate Bromide in Pharmaceutical Formulation

The present study depicts the developed and validated simple, reliable, sensitive and robust RP-HPLC method for the determination of Valethamate bromide in pharmaceutical formulation. The chromatographic system consisted of LC 2010cHT, Luna HPLC analytical C18 100 A°, 250 X 4.6 mm, 5 μm columns and the mobile phase containing acetonitrile: water in the ratio of (20: 80) % v/v. Detection was carried out by using PDA detector at 200 nm. Retention time (Rt) of Valethamate bromide was 4.62 min. Method shows to linear response in the range of 5–30 μg/ml (r²=0.9975). LOD and LOQ were 0.22 and 0.68 μg/ml, respectively. Method was validated according to ICH Q2 (R1) guidelines. Parameters taken into consideration for validation were linearity, precision, specificity, accuracy, robustness. %RSD values for all the parameters were <2%. Accuracy of the method after standard addition of the drug was within range 99.67–100.66%. Robustness study was performed using 2^3–1 factorial design. The developed method can be successfully applied to the pharmaceutical formulation for determination of Valethamate bromide.