Abstract:
This study represents a comprehensive analytical method validation study
focusing on the Dissolution method for Tiemonium Methyl Sulfate 50 mg
tablets. The investigation encompasses crucial validation parameters, including
Method Precision, Intermediate Precision, Solution Stability, System Suitability,
Specificity, Filter Evaluation, Linearity, and Accuracy. Through rigorous testing,
all parameters were found to fall within acceptable ranges, demonstrating the
robustness and reliability of the Dissolution method. Notably, the extended
Solution Stability, reaching up to 18 hours, emphasizes the method's practical
utility and consistency. These favorable outcomes collectively affirm the
suitability of the Dissolution method for routine analysis of Tiemonium Methyl
Sulfate 50 mg tablets in pharmaceutical quality control. This research contributes
valuable insights to the field, offering a validated and effective analytical
approach for ensuring the accuracy and precision of dissolution testing in
pharmaceutical formulations.
