STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF IBUPROFEN AND HYDROCODONE BITARTRATE IN THEIR COMBINED DOSAGE FORM

ABSTRACT A simple, rapid, economical, precise and accurate HPLC method for simultaneous estimation of Hydrocodone Bitartrate and Ibuprofen in their combined dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Hydrocodone Bitartrate and Ibuprofen In Their Combined Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 µm) column and Buffer (Potassium Phosphate, pH 4.5) : Methanol (50:50) at a flow rate of 1 ml/min. Detection was carried out at 223 nm. Retention time 3.303 min and 5.740 for Ibuprofen and Hydrocodone Bitartrate respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Hydrocodone Bitartrate 1.5-3.75 μg/ml and for Ibuprofen 40-120 μg/ml. The percentage recoveries obtained for Hydrocodone Bitartrate and Ibuprofen were found to be in range of 99.478 ± 1.196 and 99.917 ± 0.897 respectively. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Hydrocodone Bitartrate and Ibuprofen In Their Combined Dosage Form The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form. KEYWORDS: Hydrocodone Bitartrate, Ibuprofen, Simultaneous Estimation, HPLC Method, Validation