Simultaneously determination of paracetamol,oxolamine citrate, phenylephrine and chlorpheniramine maleate with HPLC in dosage forms

A rapid, sensitive and low cost HPLC method wasdeveloped for the simultaneous determination of the analgesic/antipireticparacetamol, antitussive oxolamine citrate, sympathomimeticphenylephrine hydrochloride and the antihistaminic chlorpheniraminemaleate in dosage forms.The drug substances from the tablets had been transferredto the organic phase as explained in chapter 3. 5. 4 and determination ofthe drug substances were performed with HPLC-PDA detector at 265 nmwavelength. The Agilent Zorbax SB-CN; 150 mm x 4.6 mm, 5 ?m columnat 22 °C had been used for assay. Injection volume was 10 ?L. Mobilephase components were acetonitrile 85:15 phosphate buffer at pH 4.00and flow rate has been adjusted for 1.5 mL/min, and the total analysistime was 3.34 min. The linearity range in the assay for standardparacetamol was 0.02-0.12 mg/mL, for oxolamine citrate 0.008-0.048mg/mL, for phenylephrine hydrochloride 0.0004-0.0024 mg/mL and forchlorpheniramine maleate 0.00016-0.00096 mg/mL and the accuracy andprecision (%RSD) assay of standards were found respectively in Table 25.Table 25. Accuracy and precision test resultsResultsParacetamolOxolaminecitratePhenylephrinehydrochlorideChlorpheniraminemaleateAccuracy 99.99 100.20 100.56 99.60Precision(% RSD)0.12 0.18 0.36 0.59USP XXIX validation parameters have been applied after thedetermining suitability of the development quantition method. In avalidation process precision, specificity, linearity and accuracy (recovery)tests have been applied.The present HPLC study provide the rapid, simple, sensitiveand accurate method for the simultaneous determination of paracetamol,oxolamine citrate, phenylephrine hydrochloride and chlorpheniraminemaleate on the drug substances and/or drug product.Key words: Paracetamol, Oxolamine citrate, Phenylephrine hydrochloride,Chlorpheniramine maleate, HPLC, Dosage Form