A Novel, stability indicating reversed phase Ultra performance liquid chromatography (UPLC) method has been developed and validated for simultaneous determination of Homatropine Methyl bromide (HM) and Hydrocodone Bitartrate (HB) related compounds in pharmaceutical dosage form. This chromatographic separation was carried out on an Acquity UPLC using reversed phase column (100 x 2.1 mm, 1.7 µm), a simple gradient program for 40 minutes used. Mobile phase A (buffer) consists a mixture of 14.5 mM sodium phosphate monohydrate, 12.8 mM sodium 1-octanesulfonate monohydrate and 13.8 mM Triethylamine pH adjusted to 2.0 with phosphoric acid, Acetonitrile used as Mobile phase B and mobile phase flow rate used constantly at 0.45 mL Min-1. The chromatography analysis was monitored at 205 nm with column oven temperature at 45 ÌŠC and injection volume as 20 µL. All the components were separated with good resolution in less than 40 minutes. The proposed method has been validated according to ICH guidelines, validation of method showed it to be Specific, Robust, Precise, Accurate and Linear over a range of analysis.
Keywords: UPLC, Homatropine Methyl bromide, Hydrocodone Bitartrate, Related compounds, Validation
