Development and validation of new spectrophotometric ratio H-point standard addition method and application to gastrointestinal acting drugs mixtures

New, simple, specific, accurate and precise spectrophotometric technique utilizing ratio spectra is developed for simultaneous determination of two different binary mixtures. The developed ratio H-point standard addition method (RHPSAM) was managed successfully to resolve the spectral overlap in itopride hydrochloride (ITO) and pantoprazole sodium (PAN) binary mixture, as well as, mosapride citrate (MOS) and PAN binary mixture. The theoretical background and advantages of the newly proposed method are presented. The calibration curves are linear over the concentration range of 5–60 μg/mL, 5–40 μg/mL and 4–24 μg/mL for ITO, MOS and PAN, respectively. Specificity of the method was investigated and relative standard deviations were less than 1.5. The accuracy, precision and repeatability were also investigated for the proposed method according to ICH guidelines.

Ratio H-point standard addition method is a new dual wavelength spectrophotometric method which utilizes the basic principles in ratio spectrophotometry and H-point standard addition method. It was successfully used for simultaneous determination of gastrointestinal drugs mixtures with several advantages over the previously mentioned two conventional spectrophotometric methods.Figure optionsDownload as PowerPoint slideHighlights
► Spectral resolution and simultaneous determination of binary mixtures.
► New developed and validated Ratio H-point standard addition method, and applied on two different binary mixtures.
► The method combines ratio spectrophotometry and H-point standard addition method.