alexa Development and validation of a micellar high-performance liquid chromatographic method for determination of risedronate in raw material and in a pharmaceutical formulation: application to stability studies.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutica Analytica Acta

Author(s): Walash M, Metwally M, Eid M, ElShaheny R

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Abstract A micellar HPLC method was developed for analysis of the antiosteoporosis drug risedronate. The analysis was carried out using a 250 x 4.6 mm id, 5 microm particle size C18 Waters Symmetry column. The mobile phase consisted of 0.02 M sodium dodecyl sulfate + 0.3\% triethylamine + 10\% n-propanol, prepared in 0.02 M orthophosphoric acid. The pH of the mobile phase was adjusted to pH 6.0, and it was pumped at a flow rate of 0.7 mL/min with UV detection at 262 nm. The method showed good linearity in the range of 2-80 microg/mL, with an LOD of 0.40 microg/mL (1.31 x 10(-6) M) and an LOQ of 1.21 microg/mL. The suggested method was successfully applied for the analysis of risedronate in raw material and a tablet formulation, with average recoveries of 99.91 +/- 1.30 and 101.52 +/- 0.30\%, respectively. The stability-indicating capability of the proposed method was proved using forced degradation. By changing the pH of the mobile phase to 4.0, the oxidative degradation product could be separated from risedronate.
This article was published in J AOAC Int and referenced in Pharmaceutica Analytica Acta

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