Stability indicating validated HPLC method for determination of RP-HPLC method development for Etofylline, Bromhexine hydrochloride and salbutamol sulphate in bulk and pharmaceutical dosage form

Abstract

A simple, rapid, precise and accurate stability indicating Reverse phase high performance liquid chromatography method was developed and validated for the quantitative determination of ET, BH and SS in bulk drug and Pharmaceutical dosage form. Separation was achieved on a ZORBAX CN 250X 4.6MM, 0.5µm, particle size column at a detection wavelength of 225 nm for all compounds, using a mobile phase consists of 0.1%OPA: METHANOL 800:500 in a Isocratic elution mode at a flow rate of 1.0ml per min. The ET peak was observed at 3.9min with peak area 93286, tailing factor 1.482 and resolution 3.647. BH peak was observed at 8.023min, with peak area 1453626, tailing factor 2.189 and resolution 5.943. SS peak was observed at 2.129 min with peak area 1875999, tailing factor 2.436. Because of the satisfactory results, less retention time, this trial was optimized. An attempt has been made to develop a new stability indicating validated RP-HPLC method for the simultaneous estimation of ET, BH and SS & UV-methods for estimation of ET, BH and SS in bulk and in dosage form. The proposed RP-HPLC, UV-Spectrophotometric methods were suitable methods for the determination of Etofylline, Bromhexine hydrochloride, and salbutamol sulphate in combination dosage forms. All the parameters of developed methods met the criteria of ICH guidelines for method validation.