Sensitive and Robust RP-HPLC Method for Determination of Valethamate Bromide in Pharmaceutical Formulation
Authors: Umang Shah, Tarang Talaviya, Anuradha Gajjar
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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 A⁰, 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) guideline. 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 23-1 factorial design. The developed method can be successfully applied to the pharmaceutical formulation for determination of Valethamate bromide.