Assay method development and validation for celecoxib dosage forms by high performance liquid chromatography Chandana O.S.S.1, Ravichandrababu R.2,* 1Department of Chemistry, KITS, Divili, Tirupathi Village, Andhra Pradesh, India 2Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, India *Corresponding Author E-mail: rrcbabu7@yahoo.in
Online published on 2 March, 2017. Abstract The main objective of the work was to develop and validate a stability indicating HPLC method for the determination of celecoxib and to perform forced degradation studies. The method was developed by Agilent HPLC with the column L11 (4.6 x 250mm, 5 μm), it has a mobile phase of monobasic potassium phosphate buffer [pH 3.0], methanol and acetonitrile in the ratio of 60: 30: 10 v/v/v. The flow rate was set at 2.0 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 μg/ml with a correlation coefficient value 0.9999. The precision is exemplified by relative standard deviation of 0.3%. Percentage mean recovery was found to be in the range of 97–99, during accuracy studies. The proposed method was found to be simple, accurate, precise, and robust and stability indicating HPLC method. Hence this method can be used for routine analysis. Top Keywords Celecoxib, HPLC, Stability indicating, method development, validation. Top |