Stability-indicating HPLC determination of XXXX in pharmaceutical formulations.

@entity2544 @entity136 @entity1172 @entity1626
A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of @entity136 in injectable dosage forms using @entity2544 as internal standard. @entity1172 was achieved on a Phenomenex Luna C-18 column (250   mm * 4.6   mm; 5 ) with a mobile phase consisting of 90% water and 10% @entity1626 (pH 7.00    0.05). The signals of @entity136 and @entity2544 were recorded at 275   nm. Calibration curves were linear in the concentration range of 0.5-50    g/mL. The correlation coefficient was 0.999 or higher. The limit of detection and limit of quantitation were 0.1498 and 0.4541    g/mL, respectively. The inter- and intraday precision were less than 2%. Accuracy of the method ranged from 100.2% to 100.4%. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition. Aqueous and oxidative stress conditions also degrade the drug. Degradation was higher in the alkaline condition compared to other stress conditions. The robustness of the methods was evaluated using design of experiments. Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis.
