RP-HPLC Method for the Simultaneous Determination of Paracetamol, Guiafenesin, Ambroxol, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate in Bulk and Pharmaceutical Dosage Form”

摘要

An RP-HPLC method for the simultaneous determination of Paracetamol, Guaifenesin, Ambroxol, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate in tablets was developed and validated as per ICH & FDA guidelines. The separation was achieved with a 228 mm x 4.6 mm, 5 μm C18 column, by using a simple linear gradient. The mobile phase A was 0.01M sodium perchlorate, monohydrate, pH 3.0 and mobile phase B was Acetonitrile. The flow rate was 1.5 mL/min and column temperature was maintained at 25?C. The gradient separation was achieved within 15 minutes. The linearity of the proposed method was investigated in the range 0.0008-0.0012 mg/mL (r2= 0.999) for Phenylephrine, 0.04-0.06 mg/mL (r2= 0.999) for Paracetamol, 0.008-0.012 mg/mL (r2= 1.000) for Guaifenesin, 0.0024-0.0036 mg/mL (r2= 1.000) for Ambroxol, and 0.00016-0.00024 mg/mL (r2= 1.000) for Chlorpheniramine. Blank and placebo did not disturb the detection of Paracetamol, Guaifenesin, Ambroxol, Phenylephrine, and Chlorpheniramine and the assay can thus be considered specific. The developed method has an advantage that all the drugs can be quantified alone or in combination using a single mobile phase.