An Advanced Analytical Technical Method for the examination of Aceclofenac and Misoprostal by using UPLC in Bulk and Pharmaceutical Dosage Forms

This method is convenient for method development and validation by using UPLC (Ultra Performance Liquid Chromatography) with the study of stability and combined tablet formation of Aceclofenac and Misoprostol by the Aquity UPLC BEH C18(50mm x 2.1m i.d.1.7 μ) column by using 0.1% TFA & Acetonitrile in the ratio of 30:70 % v/v; detection was carried out by absorption at 280nm using a photodiode array detector at ambient temperature. The total run time is 5.0 min. The validation results for adequate and the outlook was found to be acceptable limits. The above technique was used to perform a retain formation assay, which indicates that 100.24% of the formation was present. This method was validated to meet requirements for a global regulatory filling and included specificity, precision, linearity and accuracy. The linearity analysis was conducted at 10% to 150% stages with regression coefficient of 0.999. Release of more than 85% of global amount was achieved over 30 min in the medium throughout the study. The dissolution test developed was the adequate for its purpose and could be applied for quality control of misoprostol& aceclofenac formulation dosage form.