DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE SIMULTANEOUS ESTIMATION OF DOXOFYLLINE AND SALBUTAMOL SULPHATE IN PHARMACEUTICAL DOSAGE FORM

Arun Kumar Dhote*, Alok Pal Jain, Harikishor Barange and Gaurav Gupta

ABSTRACT

A new, simple, sensitive, precise, accurate and stability indicating Method has been developed and validated for simultaneous estimation of Doxofylline and Salbutamol Sulphate in Pharmaceutical oral solid tablet dosage form by RP-HPLC. The successful analysis was carried out of the marketed product by using C18, Hypersil BDS, 250mm× 4.6 mm, 5μm or equivalent at ambient temperature using Buffer: Acetonitrile (80:20v/v) as mobile phase composition. The flow rate was adjusted to 1.2mL/minute and the absorption maxima were observed on UV detector at 225 nm. Retention Time for Doxofylline 4.7±0.1min and Salbutamol 7.3±0.1min. The linearity was obtained in the concentration range of 64-96μg/mL and 16-24μg/mL for Doxofylline and Salbutamol respectively. Mean percentage recoveries were 98.87% Doxofylline and 99.14% for Salbutamol. Percentage relative standard deviation of percent assay values for replicate sample preparation was 0.73% for Doxofylline and 0.72% for Salbutamol. The method was robust with respect to change in flow rate, temperature and composition of mobile phase. The method was validated statistically and applied successfully for the determination of Doxofylline and Salbutamol. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of Doxofylline and Salbutamol in pharmaceutical oral solid tablet dosage form.

Keywords: Doxofylline, Salbutamol, RP - HPLC, Analytical Method, Method Validation.