Abstract
Background: New, simple and specific spectrophotometric methods and artificial neural network (ANN) were developed and validated in accordance with ICH guidelines for the simultaneous estimation of Olmesartan (OLM), Amlodipine (AML), and Hydrochlorothiazide (HCT) in commercial tablets.
Results: For spectrophotometric methods: First, Amlodipine (AML) was determined by direct spectrophotometry at 359 nm and by application of the ratio subtraction, the AML spectrum was removed from the mixture spectra. Then Hydrochlorothiazide (HCT) was determined directly at 315 nm without interference from Olmesartan medoxamil (OLM) which could be determined using the isoabsorptive method. The calibration curve is linear over the concentration range of 5-40, 2.5-40 and 2-40 mu g mL(-1) for AML, OLM and HCT, respectively. ANN (as a multivariate calibration method) was also applied for the simultaneous determination of the three analytes in their combined pharmaceutical dosage form using spectral region from 230-340 nm.
Conclusions: The proposed methods were successfully applied for the assay of the three analytes in laboratory prepared mixtures and combined pharmaceutical tablets with excellent recoveries. No interference was observed from common pharmaceutical additives. The results were favorably compared with those obtained by a reference spectrophotometric method. The methods are validated according to the ICH guidelines and accuracy, precision and repeatability are found to be within the acceptable limit.