METHOD DEVELOPMENT AND VALIDATION OF RELATED IMPURITIES FOR ASSAY OF OLMESARTAN MEDOXOMIL AND HYDROCHLORTHIAZIDE IN SOLID ORAL TABLETS BY RP-HPLC Authors: Damayanthi Y , TEJASWINI N, PRACHET P, RAJINI KANTH KN AND RAMA RAO. N
ABSTRACT
The purpose of this work is to develop an accurate and precise HPLC method for the
determination of Hydrochlorothiazide and Olmesartan Medoxomil in solid dosage form.
Separation of the drug was achieved on an inertsil ODS 3V 150x4.5 column using a mobile
phase consisting of 0.01M pH 3.0 phosphate buffer and acetonitrile by using a gradient
programmer. The flow rate was 1.2ml/min and the detection wavelength was 262nm. The
linearity was observed in the range of 15-90p-pm for Hydrochlorothiazide and 24-144ppm for
Olmesartan Medoxomil with a correlation coefficient of 0.999 and 0.999 respectively. The
impurities of Hydrochlorthiazide and Olmesartan Medoxomil were optimized and separated. The
proposed method was validated for its linearity, accuracy, precision and robustness. This method
can be employed for routine control analysis of Hydrochlorothiazide and Olmesartan Medoxomil
in solid dosage form by RP-HPLC.
Keywords: Hydrochlorothiazide, Olmesartan Medoxomil, impurity profiling, dosage form RPHPLC,
validation Publication date: 01/04/2020 https://ijbpas.com/pdf/2020/April/MS_IJBPAS_2020_5017.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2020/9.4.5017