No abstract

Proposed method involves simple and rapid steps of sample processing that do not require a precolumn or postcolumn derivatization procedure. The method is suitable for routine pharmacokinetic analysis and therapeutic monitoring of PGB.

No abstract

A dual wavelength UV-spectrophotometric method has been developed for the simultaneous estimation of mycophenolate mofetil and prednisolone. In this method two wavelengths were selected for the estimation of each drug in such a way that the difference in the absorbance was zero for the second drug on the respective wavelength for the fi rst drug. This method was selected because of the overlapping of the absorbance maxima of the drugs. Prednisolone has equal absorbance value at wavelengths 235.11 and 261.33 nm; therefore, these two wavelengths were used to determine the concentration of mycophenolate mofetil in the combination. Similarly, 270.3 and 277.4 nm wavelengths were selected to determine the concentrations of prednisolone, where mycophenolate mofetil was observed with equal absorbance values. Regression analysis for the method shows good correlation in the concentration ranges 10-50 μg/ml for mycophenolate mofetil and 2-10 μg/ml for prednisolone. The method was validated using parameters provided as per ICH guidelines.

Quality by design is an important tool which used by pharmaceutical manufacturer with increased self-regulated flexibility while maintaining best quality standards and fast production of the product. The concept of QBD was mentioned in the ICH Q8 guidance, which elaborate that “quality cannot be tested into products, i.e., quality should be built in by design”. Under the concept of QbD during designing and development of a product, a company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA).This paper discuss about the pharmaceutical quality by design and describes how it can be used to study the effect of process parameters on quality attributes of oral dosage forms.