HPLC Determination of Indacaterol Maleate in Pharmaceutical Preparations Adopting Ultraviolet and Fluorescence Detection

Sensitive and rapid HPLC procedure was developed for determination of Indacaterol Maleate (IND) in bulk powder and capsules using Ultraviolet and fluorescence detection. The chromatographic separation was performed on C18 column as a stationary phase, and the mobile phase consisted of acetonitrile: 5mM acid hydrogen orthophosphate containing 0.3 % triethylamine (TEA) in ratio of (40: 60% v/v) adopting both UV detection and fluorescent detection adjusted to pH 3.0 using 0.02 M orthophosphoric acid (OPA) and was passed at flow rate 1.0 mL /min. The UV detection was adjusted at 259 nm where dexamethasone was used as internal standard or fluorescence detection was at 421 nm after excitation at 258 nm where Cyproheptadine was used as internal standard. The developed method was validated according to ICH guidelines in terms of linearity, lower limit of quantification (LOQ), lower limit of detection (LOD), precision and accuracy. The absorbance-concentration plot was rectilinear over the range 2.0 - 20.0 µg /mL with a lower detection limit (LOD) of 0.116 µg /mL and lower quantification limit (LOQ) of 0.352 µg /mL adopting UV detection. Meanwhile, the fluorescence-concentration plot was rectilinear over the range of 0.05 – 5.0 µg /mL with LOD of 8.6 x 10 -3 µg /mL and LOQ of 26.1 x 10 -3 µg /mL adopting fluorescent detection The proposed method was rapid (elution time didn’t exceed 5 min) and reproducible (R.S.D. < 2.0%). The proposed method was applied successfully for the determination of Indacaterol maleate in capsule dosage form. The developed method adopting fluorescence detector is 50 times more sensitive than Ultraviolet method.