A RP-HPLC Method for Simultaneous estimation of Chlorpheniramine Maleate, Paracetamoland Phenylephrine Hydrochloride in Bulk

Abstract

Background: Chlorpheniramine maleate (CM) is used to treat sneezing, itching, watery eyes, and runny nose. It is an antihistamine drug. In combination with an analgesic paracetamol (PM) and a decongestant phenylephrine hydrochloride (PH) is commonly sold to treat cough and cold. The aim of study is to develop simple and less time consuming RP-HPLC method was determination for these three drugs in tablet dosage form.

Methodology: The parting of these drugs was carried out using phenomenexluna 5µ CN 100A (250×4.6mm×5µ) analytical column using phosphate buffer (pH 6.2): Acetonitrile (70:30 v/v) mobile phase. The elution rate was set at 1 ml/min and 45^OC is the column temperature. The UV detector set at 215nm.

Results All three drugs were separated effectively, 2.43 min is the  retention time of CM, 3.75 for PM and 7.84 min for PH at 215 nm. 0.999, 0.998 and 0.999 is the correlation coefficient for CM, PM and PH respectively. The relative standard deviation was found to be below 2% for six replicates. The method parameters were validated according to ICH guidelines.

Conclusion: it is concluded that the proposed method can be effectively applicable to the pharmaceutical dosage forms having these drugs in combination without any interference of excipients.