Method Development and Validation for Simultaneous Estimation of telithromycin and Ketoprofen by RP-HPLC
The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of telithromycin (TLM) and ketoprofen (KP). C18 column (chromosil ODS, 4 𝜇m, 200× 4.0mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate(0.005 M) adjusted to pH 3.2: acetonitrile (45 : 55 v/v) mixture was used for the separation and quantification. The flow rate was0.8 mL/min and the eluents were detected by UV detector at 225 nm. The retention times were found to be 3.48 and 5.42 mins, respectively.The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 𝜇g/mL for both drugs. The developed method was applied successfully for assay of telithromycin and ketoprofen in their combined in-house developed dosage forms and in vitro dissolution studies.
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