Analytical Development and Validation of Ramipril and Hydroclorothiazide in Bulk and Tablet Dosage Form using Rp-HPLC

Abstract

A new analytical method development of Ramipril and Hydroclorothiazide in bulk and tablet dosage form was performed, using RP-HPLC. An original method was developed using Hypersil C18 column with mobile phase arrangement of Acetonitrile: Phosphate buffer (75:25) at a flow rate of 1.0 ml/min and UV detection at 235nm for Hydrochlorothiazide and 220nm for Ramipril. The technique was authenticated as per ICH guidelines and Linearity was experiential over concentration range of 15 to 25µg/ml for Ramipril and 30-60 µg/ml for Hydrochlorothiazide. Assay was performed by taking marketed tablet formulation (Rip-H) In the present study, a simple, sensitive, precise and accurate RP-HPLC method was developed for the quantitative estimation of Ramipril and Hydrochlorothiazide in bulk drug and pharmaceutical dosage forms. This method was simple and was performed without any preliminary chemical derivatisation or purification steps. Ramipril and Hydrochlorothiazide are easily soluble in ethanol, methanol and sparingly soluble in water. Acetonitrile: TEA Buffer pH 4.2 (75:25) was chosen as the mobile phase. The solvents used in this validation method were economical. The %Relative Standard Deviation values were found to be less than 2 and the method was found to be precise. All the results obtained were found to be within the limits. Hence, this  method is more sensitive, accurate and precise compared to other  methods. This method can be used for the routine determination of Ramipril and Hydrochlorothiazide in bulk drug and in pharmaceutical dosage forms.