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ISSN: 2157-7048

Journal of Chemical Engineering & Process Technology
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Research Article

Process Validation of Ceftriaxone and Sulbactam Dry Powder Injection

Shiv Sankar Bhattacharya1*, Naveen Bharti1 and Subham Banerjee2
1School of Pharmaceutical Sciences, IFTM University, Moradabad, Uttar Pradesh, India
2Division of Pharmaceutical Technology, Defence Research Laboratory, Tezpur, Assam, India
Corresponding Author : Shiv Sankar Bhattacharya
School of Pharmaceutical Sciences, IFTM University
Delhi Road, Moradabad-244 001, Uttar Pradesh, India
Tel: 0341-2313120
E-mail: [email protected]
Received October 10, 2014; Accepted October 28, 2014; Published October 31, 2014
Citation: Bhattacharya SS, Bharti N, Banerjee S (2014) Process Validation of Ceftriaxone and Sulbactam Dry Powder Injection. J Chem Eng Process Technol 5:211. doi:10.4172/2157-7048.1000211
Copyright: © 2014 Bhattacharya SS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Abstract

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.

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