Authors : A. Raja Reddy; Atika Afreen; T. Rama Rao

Volume/Issue : Volume 9 - 2024, Issue 8 - August

Google Scholar : https://tinyurl.com/3ttwd65m

Scribd : https://tinyurl.com/mwpex6vu

DOI : https://doi.org/10.38124/ijisrt/IJISRT24AUG725

Abstract : Analytical method validation is a crucial step in ensuring the reliability and accuracy of analytical procedures employed for the determination of active pharmaceutical ingredients (APIs) in pharmaceutical dosage forms. This study focuses on the validation of analytical methods for the quantification of trithioparamethoxy phenylpropene and chlorpheniramine maleate in pharmaceutical dosage forms. The methods were developed using high- performance liquid chromatography (HPLC) or using ultra performance liquid chromatography (UPLC) with appropriate detection techniques. Parameters such as specificity, linearity, precision, accuracy, robustness, ruggedness, range, stability, LOD, LOQ and system suitability were evaluated according to International Conference on Harmonization (ICH) guidelines. The validated methods demonstrated excellent specificity, linearity over a wide concentration range, precise and accurate results, robustness against variations in method parameters, and suitable system suitability. The validated methods are suitable for routine quality control analysis of pharmaceutical formulations containing trithioparamethoxy phenylpropene and chlorpheniramine maleate, ensuring the reliability and consistency of drug products.

Keywords : Analytical Method Validation; Chlorpheniramine Maleate; Antiallergic Agent; Trithioparamethoxy Phenylpropene; Hepatoprotective Agent.

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