DOI: 10.36347/sajp

Pages: 16-23

To develop and validate a simple& accurate Spectrophotometry methods for simultaneous estimation of Ketotifen and Salbutamol in their combined pharmaceutical dosage form. Two simple, accurate, precise U.V Spectroscopy methods have been developed. First method was based on Simultaneous Equation method. Here 301 nm was selected for the estimation of Ketotifen& 276 nm selected for estimation of Salbutamol. The second method was Dual wavelength method, Here 284 nm & 267.84 nm selected for the estimation of Ketotifen where Salbutamol show same absorbance. Other 315 nm & 284.59 nm selected for estimation of Salbutamol where Ketotifen show same absorbance. Ketotifen and Salbutamol showed linearity in the range of 5-25μg/ml and 10- 50μg/ml respectively in both methods. Both methods were validated by validation parameters and it show result where lie within its acceptance criteria as per ICH Q2 (R1) guideline. Hence, it can be successfully used for the routine analysis of Ketotifen and Salbutamolin their combined pharmaceutical dosage forms