Zeitschrift für Chemieingenieurwesen und Prozesstechnologie
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Process Validation of Ceftriaxone and Sulbactam Dry Powder Injection

Shiv Sankar Bhattacharya, Naveen Bharti and Subham Banerjee

In the present work Process validation of Ceftriaxone and Sulbactam as a dry powder injection was carried out. As the manufacturing process of dry powder injection is mainly dependent on blending process. In the present investigation, blending process was validated at different speeds of blender and the % assay was estimated by HPLC method. The octagonal blender was operated at 13, 17 and 20 rpm samples were taken from 10 different locations inside the blender. At 13 rpm there is much variation in assay results, at 17 rpm there is very less variation and also at 20 rpm there is slight variation occurs with reference to the acceptable ranges of assay {i.e. 90-110 %}. The obtained results clearly indicated that the optimum rpm is often necessary for the proper mixing of the drug. Therefore, 17 rpm was considered for the proper mixing at blending stage and it can be successfully employed to manufacture of dry powder injections for further manufacturing. The content uniformity of the net filled content was found to be in ± 5 % of average net content. Hence, it was concluded that process stands validated for the preparation of dry powder injection.