Stability - Indicating Hplc Assay for Paracetamol, Guaiphenesin, Sodium Benzoate and Oxomemazine in Cough Syrup.

Abstract

Abstract A stability-indicating, specific, sensitive and validated reversed-phase HPLC assay for paracetamol, guaiphenesin, sodium benzoate and oxomemazine in the presence of degradation products, i.e. 4-aminophenol and guaicol, as well, as the co-formulated adjuvants and 5-hydroxymethylfurfural, a commonly formed compound in syrups during formulation and/or storage of pharmaceutical syrups, has been developed to allow simultaneous determination of these compounds in a cough syrup. The HPLC method includes the use of a two-line solvent delivery system. The specificity, precision in term of both repeatability (i.e. intraday precision) and reproducibility (i.e. interday precision), limit of detection of the degradation products and ruggedness due to column to column batch and source variation have been discussed. The developed method has been applied for the determination of the main drugs and their degradation products in freshly prepared as well as in stored samples of cough syrup. Key Words: Stability-indicatingparacetamoloxomemazineguaiphenesinsodium benzoateHPLC assaycough syrup