Quality Studies For A Ceclofenac Raw Materials And Enteric-coated Capsules

Aceclofenac is a new type of non-steroidal anti-inflammatory drugs,with the high therapeutic index and low ulcer index.At present,there are a variety of preparation products in the China market.Aceclofenac enteric-coated capsules,which only dissolve in the gut,greatly reduce the collapse cancer effect that the stomach caused.Aceclofenac enteric-coated capsules can be assimilated more fully,the side effects were significantly lower than other similar drugs.This drug has significantly anti-inflammatory,analgesic and antipyretic effect;In this paper,the analysis method has been improved and the quality study of the aceclofenac raw materials and enteric-coated capsules has been finally completed.A High Performance Liquid Chromatography method was established for the aceclofenac content and content uniformity.In the HPLC method C18 column was used with the mobile phase of phosphate buffer(adjusted with phosphoric acid to pH=7.0)acetonitrile-methanol=40:30:30,at the detection wavelength of 275 nm,the flow rate of 1.0 mL/min,column temperature is 30℃ and injection volume is 20 μL.The calibration curve.of aceclofenac was linear in the concentration range of 1.02μg/mL～51.0μg/mL.The stability test showed that aceclofenac is relatively stable when dissolved in methanol.RSD was less than 2.0%.A gradient HPLC method was also established for the determination of related substances in this paper.In the HPLC method,C18 column was used with gradient elution,at the detection wavelength of 275 nm,the detection time is 45 min and the column temperature is 30℃.The results showed that aceclofenac and its known impurities have good linear relationship within their respective linear ranges.In these conditions,the resolution of Aceclofenac and each impurity is more than 1.5,excipients and degradation products do not interfere with the main peak.The chromatographic condition with good precision,high accuracy,and strong specificity,can be used for the detection of aceclofenac raw materials and the enteric-coated capsules.The quality study of aceclofenac raw materials and the enteric-coated capsules was completed in this paper.The characters of aceclofenac raw materials and the enteric-coated capsules were investigated.Methods of high-performance liquid chromatography and UV spectrophotometry were respectively established to identify them.The inspections of the related substances,loss on drying,content uniformity,dissolution were also completed in this study.The stability of aceclofenac raw materials and enteric-coated capsules were investigated.Results showed that there were no significant changes for the contents and the related substances of the three batches of aceclofenac raw materials and enteric-coated capsules.