A stability indicating, simple, economic, rapid, precise and sensitive reverse phase high performance liquid chromatography method was developed and validated for determination of Omeprazole and Diclofenac sodium in capsule dosage form. The quantitative determination of Omeprazole and Diclofenac sodium was performed on an BDS Hypersil C18, 250 mm X 4.6 mm, 5 µm, stainless steel analytical column from Thermoscientific with mobile phase consist of Ammonium acetate buffer (0.05M) :Acetonitrile (55:45 %v/v), pumped at a constant flow rate of 1 mL min-1. The detection is carried out using variable wavelength UV-Vis detector set at 289.0 nm. The method shows good peak shape, minimal tailing, with retention time 4.79 min and 6.62 min for Omeprazole and Diclofenac sodium. The both drugs was subjected to acidic, alkaline, oxidation, photo-degradation to apply stress conditions. The developed method was able to separate degradation product generated under forced degradation studies. The developed method was validated as per ICH guidelines for the parameters such as specificity, linearity, accuracy, precision, limit of detection, limit of Quantitation and found to be satisfactorily. The response was linear in the drug concentration range of 4-20 µg mL-1 (r2 = 0.998) and 20-100 µg mL-1 (r2 = 0.998) for Omeprazole and Diclofenac sodium. The proved to be suitable for stability testing, homogeneity testing and quality control of this compound in capsule dosage form.
Loading....