Stability Indicating Rp-Hplc Method Developme...

Stability Indicating Rp-Hplc Method Development and Validation for the Simultaneous Estimation of Alcaftadine and Ketorolac Tromethamine in Pharmaceutical Dosage Form

Author Name : Ishani Patel, Dr. Nishkruti Mehta, Dr. Pankti Dalwadi, Ms. Neetu Dharu

ABSTRACT

A reverse phase high performance liquid chromatography method was developed for the simultaneous estimation of Alcaftadine and Ketorolac Tromethamine in Pharmaceutical dosage form has been developed. The separation was achieved by Hyperchrom ODS C18 Column (250*4.6mm) column and Buffer 0.05M Potassium dihydrogen ortho phosphate Buffer (pH-4.0): Methanol (60:40) as a mobile phase, at a flow rate 1ml/min. Detection was carried out at 220nm. Retention time of Alcaftadine and Ketorolac Tromethamine were found to be 3.187 and 5.497 respectively. The method has been validated for linearity, accuracy, precision and robustness. Linearity observed for Alcaftadine and Ketorolac Tromethamine 12.5-37.5 μg/ml and 20-60 μg/ml respectively. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Alcaftadine and Ketorolac Tromethamine in Pharmaceutical dosage form. The drug was subjected to stress condition of acid, base, oxidation, photolysis and thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form.

Key Words: Alcaftadine, Ketorolac Tromethamine, Stability indicating RP-HPLC method, Validation method