Stability indicating HPLC method for celecoxib related substances in solid dosage forms

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چکیده

The main objective of the research work was to develop a simple, accurate, stability indicating RP-HPLC method for the quantification of celecoxib and its related substances which can be able to quantify the degradation products and also to get good baseline separation between celecoxib and its process related impurities and degradation products. The method was developed by Agilent HPLC with the column L11, (4.6x250mm, 5μ), Supelcosil DP, it has a mobile phase of Mixture of Buffer, Methanol and Acetonitrile in the ratio of 60: 30: 10v/v/v was used. The flow rate was set at 1.3 ml/min with a detection wavelength of 215nm using VWD detector. The method was validated for analytical parameters such as specificity, accuracy, precision, robustness and ruggedness as per ICH guidelines. The linearity was found to be in the range of 25-120 g/ml with a correlation coefficient value 0.9991, 0.9986, 0.9990, 0.9992 and 0.9990.Hence this method can be used for routine analysis.

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تاریخ انتشار 2017