RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF KETOTIFEN FUMARATE AND THEOPHYLLINE IN BULK AND COMBINED DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 5
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 Phosphate Buffer: Methanol (pH-3.0) (60:40 %V/V) mobile phase at 10 minutes. run time and 295 nm. The Rt value for Ketotifen fumarate and Theophylline were found to be 6.13 ± 0.01 minutes and 3.34 ± 0.01 minutes 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. The %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 analysis of the sample. Interference studies reveals that the common excipients and other additives usually present in the dosage form did not interfere in the proposed method. So it is concluded that the developed method is specific. The system stability test parameters were also performed and were found to be within acceptable criteria. The method can be successfully employed for the simultaneous determination of Ketotifen fumarate and Theophylline in pharmaceutical formulation.
Authors and Affiliations
Narendra Chaudhari
Keywords
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- EP ID EP105015
- DOI 10.7897/2230-8407.050585
- Views 141
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