Development and validation of analytical methods for multicomponent crystals of ibuprofen with malic and tartaric acid using spectrophotometry

Abstract

Various chemical substances have been used as pharmaceutical active ingredients, such as ibuprofen, which is an analgesic. The validity of an analytical method of a pharmaceutical active ingredient combined with co-formers into one single phase should be confirmed so that the analysis can be well received. Therefore, this study aims to validate the analytical method of ibuprofen in multicomponent crystals using a UV spectrophotometer with the parameters of linearity, accuracy, precision, and placebo interference. Ibuprofen was dissolved in phosphate buffer with a pH of 7.2 using ethanol as co-solvent. The solution was diluted and analyzed to obtain the maximum wavelength. The calibration curve was analyzed to obtain the linear regression equation for ibuprofen to determine linearity. The accuracy and precision parameters were measured by the results of replications. Meanwhile, placebo interference was determined using an equimolar ratio of 1:1 between ibuprofen with malic acid and tartaric acid. The results of the analysis showed that ibuprofen had a maximum wavelength of 265 nm. The linearity, accuracy, precision, and placebo interference fulfilled the requirement. Based on the validation parameter performed, the analytical method used was valid for the analysis of ibuprofen multicomponent crystals with malic acid and tartaric acid as co-formers.