Analytical Method Development and Validation of Posaconazole by QbD Approach
International journal of pharmaceutical sciences review and research
Quality by design (QbD) is modern and systematic approach for product development and quality of pharmaceuticals. In this concept of QbD it is essential to define desire product performance profile, analytical target Profile and identify critical quality attributes throughout designing and development of a process. This review aimed to identify implementation of QbD in analytical procedure validation. Integration of QbD is an essential step in developing a systematic method which effectively
... for purpose and assures quality. The outcomes of organized analytical process development and validation are understandings of critical quality attributes, risk assessment and outlining design space. Consequently, control strategy can be set for further investigation or other issues. Posaconazole is a approved lipophilic triazole antifungal agent that exhibits potent and broad- spectrum antifungal activity in vitro and in vivo against most Candida spp., Cryptococcus neoformans, Aspergillus spp., many Zygomycetes, endemic fungi and dermatophytes. It has been documented that posaconazole has potency and spectrum of activity similar to those of itraconazole and superior to those of fluconazole against clinically important isolates of Candida spp., C. neoformans and Aspergillus spp. A spectrophotometric method has been developed and validated for the determination of Posaconazole in pharmaceutical formulation. QbD approach was carried out by varying 19 parameters and critical parameters were extracted by using principal component analysis and by observation. The extracted critical parameters are summarized in Table 7.1. PCZ followed linearity in the concentration range of 10–50 g/mL. The proposed method was applied for pharmaceutical formulation and percentage label claim was found to be 99.05%. The amount of drug estimated by proposed method was in good agreement with the label claim. The method was found to be precise as indicated by the inter-day and intra-day analysis showing % RSD less than 2. There was no any interference of excipients showing that the method was specific. Limit of detection and limit of quantitation were 0.09 and 0.27 g/mL, respectively.