Jornal de Cromatografia e Técnicas de Separação
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Abstrato

Determination of Pseudoephedrine HCL and Levocetirizine HCL in Combination Dosage Form by High Pressure Liquid Chromatography

Arunadevi S. Birajdar, SN Meyyanathan

An accurate and reproducible liquid chromatographic assay method was developed and validated for the determination of Pseudoephedrine HCL and Levocetirizine HCL in Tablet formulation. Acetonitrile and Water (50:50 v/v) was used for reverse-phase liquid chromatography at detection wavelength 230 nm to determine the contents of Pseudoephedrine HCL and Levocetirizine HCL in Tablet formulation. The method was validated by determining parameters such as specificity, linearity, LOD and LOQ, precision, accuracy, ruggedness and robustness. The method was found to be specific against placebo interference. Linearity was evaluated over the concentration range of Pseudoephedrine HCL 10-120.0 μg/mL and Levocetirizine HCL 0.5 to 12.0 μg/mL. The correlation of coefficient obtained was 0.998 for both. The intraday and interday precision values of the system and method was determined. The accuracy of the method obtained 99.98% for Psedoephedrine HCL and 100.50% for Levocetirizine HCL. The proposed method was found robust, while there was slight but deliberate changes were made in analytical conditions. The developed will be suitable for the assay of in raw materials, capsule formulation as well in other forms of combined dosage forms.