Shripad, Deepak D. Kayande, Mazahar Farooqui, Parag Deshmukh

Poly (lactide-co-glycolide acid) ( PLGA) is an extraordinary well-described polymer and has excellent pharmaceutical properties like high biocompatibility and good biodegradability. Hence, it is one of the most used materials for drug delivery and biomedical systems, also being present in several US Food and Drug Administration approved carrier systems and therapeutic devices. For both applications, the quantification of polymer is important. During the development of the production process, parameters like yield or loading efficacy are essential to be determined. Although PLGA is a well-defined biomaterial, it still lacks a sensitive and convenient quantification approach for PLGA-based systems. Thus, we present a new method for fast and precise quantification of PLGA by HPLC-SEC. The method includes a shorter run time of 20 minutes with a size exclusion column of 300mm x 8.0mm diameter, tetrahydrofuran as mobile phase and diluent, the detection was carried out using the refractive index detector. The developed method has a detection limit of 0.1 ppm, enabling the quantification of low amounts of PLGA. Compared to existing approaches, like gravimetric or nuclear magnetic resonance measurements, which are tedious or expensive, the developed method is fast, ideal for routine screening and it is selective since no interference. The developed method is validated in terms of selectivity, precision, linearity, accuracy and solution stability. Due to the high sensitivity and rapidity of the method, it is suitable for both, laboratory and industrial use 


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