Ibrahim Baje Syed , Madhavi Nannapaneni

Abstract

A new, simple, responsive, and stable RP-HPLC technique for measuring Olanzapine and Samidorphan's active pharmaceutical components was developed and validated in this study. RP-HPLC technique for the quantitative measurement of Olanzapine and Samidorphan that has been verified and has a well defined stability. Using an Inertsil ODS column with dimensions of 250x4.6 mm and a 5 micron isocratic elution with an acetonitrile/0.1 percent ortho phosphoric acid mobile phase, we developed a chromatographic method (50:50). Instrumental conditions included a stream rate of 1 ml/min and a detection absorbance of 261 nm using the photo diode array detector. To speed up the chromatographic process, an impurity-spiked solution was used instead of water. An international conference on harmonisation (ICH) set rules for validating the proposed approach, which were followed throughout validation. A regression value of R2 > 0.999 shows the linearity of the calibration charts was within the limit. In test conditions, the suggested approach is rapid, simple, practicable, and reasonably priced. For regular examination of manufacturing samples and for verifying the quality of medication samples during stability studies, it may be used.