Development and Validation of RP-HPLC Assay Method for Simultaneous Determination of Ranitidine-Hydrochloride and Domperidone in Combined Tablet Dosage Form

Quality is important and essential in every product or service but it is more vital in medicine as it relates to life. As a matter of fact, quality is built in from the time of inception of the thought to make a product to the time it is finally made and sent out. Analytical chemistry is mainly concerned with determining the qualitative and quantitative composition of material under study. Analytical monitoring of Pharmaceutical products, or of specific ingredients within the product, is necessary to ensure its safety and efficacy throughout all phases of its shelf-life, including storage, distribution and use. Pharmaceutical analysis comprises of the procedures necessary to determine the identity, strength, quality and purity of drug substances. Analytical chemistry can be divided into areas called as qualitative analysis and quantitative analysis.

It deals with the identification of substances. It is concerned with what elements or compounds are present in a sample.

It provides numerical information concerning the quantity of some species [the analyte] in a measured amount of matter [the sample]. Analytical techniques play a very important and active role in various studies carried out in pharmaceutical analysis. The major areas are:

Assay of the drug from raw materials, bulks drugs and formulations.

Detection and quantification of probable impurities and metabolites.

Accelerated stability studies.

In-vitro dissolution studies.

Quantitative estimation of drugs and/or its metabolites from biological fluids

A simple reverse phase HPLC method was developed for the simultaneous estimation of Ranitidine hydrochloride and Domperidone present in combined tablet dosage forms. Efficient chromatographic separation was achieved on Phenomenax C₁₈ stationary phase (250 X 4.6 mm i.d., 5μ particle size) with simple mobile phase combination of phosphate buffer: acetonitrile: methanol 40: 30: 30 (V/V/V) in an isocratic mode at a flow rate of 1.5 mL min⁻¹ at 210 nm. The retention times were 2.417 and 7.375 (±0.5) min for Ranitidine hydrochloride and Domperidone respectively. The proposed method has been applied successfully for the simultaneous analysis of Ranitidine hydrochloride and Domperidone in combined tablet dosage form with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of Ranitidine hydrochloride and Domperidone in pharmaceutical dosage form.