Development & validation of HPLC method for analysis of some antihypertensive agents in their pharmaceutical dosage forms

Abstract

A simple, precise, fast and gradient, high performance liquid chromatographic (HPLC) method was developed and validated for the determination of Aliskiren, Ramipril, Valsartan and Hydrochlorothiazide in solid dosage forms. The quantitative determination of analyte(s) was performed on a PUROSPHERE STAR RP 18e analytical column (250×4.6 mm) with 0.2 %v/v TEA buffer (pH: 3.0): ACN as mobile phase, at a flow rate of 1.0 mL min-1. Detection was made by extracting PDA spectra at 215 nm respectively. During method validation, parameters such as precision, linearity, stability, Robustness, Ruggedness and specificity were evaluated, which remained within acceptable limits. The method has been successfully applied to assess the assay of solid dosage formulations.