Chapter 2 Objective

Aim And

2.3 AIM AND OBJECTIVE

The literature review reveals that numerous works have been carried out on RP-HPLC, capillary zone electrophoresis, spectrophotometric methods for the quantification of Codeine phosphate, Chlorpheniramine maleate and Sodium benzoate either individually or in combination with other drugs. The combination of Codeine phosphate, Chlorpheniramine maleate active drugs and Sodium benzoate as preservative is used in pharmaceutical preparations as cough syrup. This formulation is marketed by M/s Vivimed labs ltd, Hyderabad as a cough syrup. Codeine phosphate acts as antitussive, Chlorpheniramine maleate acts as antihistaminic and Sodium benzoate acts as preservative and pH stabilizer in the formulation. The need for determination of Sodium benzoate in the present study is that it is physically and chemically compatible for syrup formulation which improves shelf life of product. In this respect, a method for the analysis of this combination is needed for simultaneous quantification of all three combined components in one step. The present study describes the development of a new rapid, efficient and reproducible RP-HPLC method using gradient mobile phase for the analysis of Codeine phosphate, Chlorpheniramine maleate and Sodium benzoate preservative in combination in cough syrup that offers certain advantages in its simplicity and time saving and applicable in routine analysis. It also describes the development of validation work as per ICH Q2B guidelines recommended by the Food and Drug Administration (FDA) of the United States.

RVS college of Pharmacy, Coimbatore

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