Study On The Quality Standards Of A Combination Tablet Product Of Pioglitazone Hydrochloride And Glimepiride

A combination tablet product of pioglitazone hydrochloride and glimepiride is a new anti-diabetic drug, which shows a potent depressive effect on diabetic hyperglycemia and is useful for treatment of diabetes. Pioglitazone hydrochloride is an insulin sensitivity enhancer, which can inhibit insulin resistance and consequently enhance insulin sensitivity. Glimepiride is an insulin secretion enhancer, which has the property to promote secretion of insulin. This new combination product has shown a marked synergistic effect compared with administration of either active component alone. The results of clinical studies have indicated that this new pharmaceutical composition was more effective.At present, no quality standards and analytical methods of the new pharmaceutical composition are listed in any pharmacopoeias. This work involves the study of comprehensive analytical methods and quality standards on the new combination product according to current technical requirements of a new drug issued by both FDA and SFDA. The quality control methods, stability programs, and quality standards are developed according to those posted for the single pioglitazone hydrochloride and glimepiride product as well as study results of the new combination product.The current study was focused on methods for dissolution, related substances and stability indicating assay. HPLC methods were established for determination of pioglitazone hydrochloride and glimepiride content and related substances. The determination method of dissolution was also proposed. The validation of analytical methods was finished according to the ICH guidance. The methods were proved to be accurate and reliable with high selectivity, sensitivity and reproducibility, which is suitable for the quality control of the new pharmaceutical composition.In the stability study, forced degradation, accelerated and long-term stability testing were performed. Scientific rationales were provided for manufacturing, packaging, storage and transportation of the new combination product. At the same time, the shelf life of the new drug product was determined based on the test results.The analytical procedures and quality standards established in the paper can provide efficient analytical methods and estimation standards for the new production as well as its quality control. This study was the analytical partion of the new drug registration with SFDA. At the same time, the standards formulated by this study can be used to control the quality of the product effectively during commercial manufacturing.