Selvadurai Muralidharan1, Kalaimani Jayaraja Kumar2, Subramani Parasuraman3. 1. Unit of Pharmaceutical Chemistry, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah, Malaysia. 2. Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah, Malaysia. 3. Unit of Pharmacology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah, Malaysia.
Abstract
OBJECTIVE: To develop a simple and sensitive method of ketorolac in drug free human plasma using high-performance liquid chromatographic (HPLC). METHOD: Ketorolac from blank plasma was extracted using protein precipitation method. Trichloro acetic acid (10%) was used as a protein precipitating agent and the percentage of recovery was calculated by adding known volume of dexibuprofen as internal standard. The HPLC separation was achieved on reversed-phase C18 column and the separations were detection by Photodiode Array (PDA) detector at 306 nm. Acetonitrile and 5 mM ammonium acetate (pH 3.5), in the ratio of 60:40% v/v was used as mobile phase at the isocratic flow rate of 1.0 ml/min. The method was validated according to FDA Guidance for Industry. RESULT: The percentage of recovery of ketorolac was 93.7 ± 0.12 (mean ± SD; n = 5). The linearity was achieved in this method range of 10.0-125.0 ng/ml with regression coefficient range of 0.999. CONCLUSION: Ketorolac bioanalytical method was developed and validated according to FDA Guidance for Industry.
OBJECTIVE: To develop a simple and sensitive method of ketorolac in drug free human plasma using high-performance liquid chromatographic (HPLC). METHOD:Ketorolac from blank plasma was extracted using protein precipitation method. Trichloro acetic acid (10%) was used as a protein precipitating agent and the percentage of recovery was calculated by adding known volume of dexibuprofen as internal standard. The HPLC separation was achieved on reversed-phase C18 column and the separations were detection by Photodiode Array (PDA) detector at 306 nm. Acetonitrile and 5 mM ammonium acetate (pH 3.5), in the ratio of 60:40% v/v was used as mobile phase at the isocratic flow rate of 1.0 ml/min. The method was validated according to FDA Guidance for Industry. RESULT: The percentage of recovery of ketorolac was 93.7 ± 0.12 (mean ± SD; n = 5). The linearity was achieved in this method range of 10.0-125.0 ng/ml with regression coefficient range of 0.999. CONCLUSION:Ketorolac bioanalytical method was developed and validated according to FDA Guidance for Industry.