Highly Accurate and Reliable RP-HPLC Approach for the Measurement of Valethamate Bromide in Pharmaceutical Compounds
Keywords:
Factorial DesignFactorial Design, Validation, RP-HPLC, ICH guideline, Valethamate bromide (VLB)Abstract
The developed and confirmed RP-HPLC technique for the measurement of Valethamate bromide in
pharmaceutical formulation is presented in this paper. The method is simple, reliable, sensitive, and robust.
The mobile phase was composed of acetonitrile and water in a ratio of 20:80 % v/v. The chromatographic
system included LC 2010cHT, Luna HPLC analytical C18 100 A⁰, 250 X 4.6 mm, 5 μm columns. At 200
nm, a PDA detector was used for detection. The half-life of valethamate bromide was 4.62 minutes. In the
5-30 µg/ml range, the method demonstrates a linear response (r2=0.9975).LOQ was 0.68 µg/ml and LOD
was 0.22 µg/ml. Following the requirements laid forth by ICH Q2 (R1), the method was verified. Linearity,
precision, specificity, accuracy, and robustness were the parameters that were validated. There was less
than a 2% RSD for all of the metrics. The method's accuracy ranged from 99.67 to 100.66% after the
typical addition of the medication. A research was conducted to assess robustness using a 23-1 factorial
design. The described approach may be used to determine the concentration of Valethamate bromide in
pharmaceutical formulations
