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Abstract
A new simple, rapid, and sensitive liquid chromatographic method has been developed and validated for the simultaneous determination of caffeine, paracetamol, pseudoephedrine, aspirin, dextromethorphan, and chlorpheniramine in pharmaceutical tablet formulations and was performed on conventional C18 and monolithic silica C18 columns. Chromatographic separation was achieved by using a mixture of methanol and a buffer containing 10 mM NaH2PO4, 3 mM heptane sulfonic acid sodium salt, 0.1% triethylamine, pH 2.5 (adjusted with hydrochloric acid) in a ratio 50:50 v/v, 40:60 v/v for conventional C18 and monolithic silica C18 columns, respectively. Quantitation was achieved with UV detection at 214 nm, based on peak area. The proposed method could be used in the presence of salicylic acid as impurity or decomposition product in dosage forms containing aspirin. The proposed method was validated and successfully applied for the analysis of pharmaceutical formulations and laboratory-prepared mixtures containing these multicomponent combinations.
Notes
a Percentage recovery from the label claim amount.
b Theoretical values for t and F at P = 0.05.
c For standard addition of 50% of the nominal content.
a Percentage recovery from the label claim amount.
b Theoretical values for t and F at P = 0.05.
c For standard addition of 50% of the nominal content.
a Y = a + bC, where C is the concentration of PR, CF, PS, AS, CH, and DX in µg mL−1 and Y is the peak area.
b 95% confidence limit.
a Y = a + bC, where C is the concentration of PR, CF, PS, AS, CH, and DX in µg mL−1and Y is the peak area.
b 95% confidence limit.
a Percentage recovery from the label claim amount.