RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF KETOTIFEN FUMARATE AND THEOPHYLLINE IN BULK AND COMBINED DOSAGE FORM

Abstract

A simple, accurate and precise RP - HPLC method for the simultaneous estimation of Ketotifen fumarate and Theophylline in Bulk and Dosage form has been developed and validated. Separation of drugs was carried out using Pho sphate Buffer: Methanol (pH - 3.0) (60:40 %V/V) mobile phase at 10 min utes . run time and 295 nm. The R t value for Ketotifen fumarate and Theophylline w ere found to be 6.13 ± 0.01 minutes and 3.34 ± 0.01 mi nutes respectively. The drug response with respect to peak area was linear over the concentration range 0.25 - 0.75 μg/ml (n = 5) for Ketotifen fumarate and 50 - 150 μg/ml Theophylline. The percentage recovery of Ketotifen fumarate and Theophylline was found to be 99.79 - 100.08 % and 99.60 - 99.86 % respectively. T he %RSD values for intra - day precision study and inter - day study were ≤ 2.0 %, confirming that the method was sufficiently precise. The limit of detection and limit of quantitation were found to be 0.0348 μg/ml and 0.1055 μg/ml for Ketotifen fumarate and 3 .4735 μg/ml and 10.5260 μg/ml for Theophylline. The %RSD values of Robustness study were ≤ 2.0 %, confirming that the proposed method was found to be robust enough to withstand such deliberate changes and allow routine a nalysis of the sample. Interference studies reveals that the common excipients and other additives usually present in the dosage form did not interfere in the pr oposed method. So it is concluded that the developed method is specific. The system stability test parameters were also performed a nd were found to be within acceptable criteria. The method can be successfully employed for the simultaneous determination of Ketotifen fumarate and The ophylline in pharmaceutical formulation. Keyword : Keto tifen fumarate, Theophylline, RP - HPLC