Author(s): Neha Sawant, Jawed Akhtar, Stavan Master

Email(s): antneha105@gmail.com

DOI: Not Available

Address: Neha Sawant1*, Jawed Akhtar1 and Stavan Master2
1Department of Quality Assurance, Parul Institute of Pharmacy and Research, Affiliated to Gujarat Technological University, Limda, Ta. Waghodia. Dist. Vadodara – 391760, Gujarat, India.
2Department of Quality Assurance, Osaka Pharmaceuticals Pvt. Ltd. Sakarada, Gujarat, India.
*Corresponding Author

Published In:   Volume - 6,      Issue - 7,     Year - 2013


ABSTRACT:
The purpose of research investigation was to conduct con-current process validation of Metformin Hydrochloride 500 mg tablet dosage form. Quality cannot be merely assured by in-process and finished product testing but it should be built in the manufacturing process by controlling critical parameters which in turn produces product meeting predetermined specifications and quality attributes. For con-current validation three consecutive batches were selected. All instruments required to carry out con-current validation were calibrated as per SOPs. All raw materials used in the manufacturing of the product were verified for the release status. Tablet was manufactured by wet granulation method. Granulation was excellent at 15 minutes because SD was between 0.0058-0.0321.Drying was excellent at 25 minutes because %LOD was less than 3% and bulk Density was within 0.7-0.9 gm/cc. Blending was excellent at 25 minutes because SD was 0.0058-0.3828. For compression parameters like Average weight, Weight of 20 tablets, Hardness, Thickness, Diameter, Friability and Assay were according to specification. For Coating parameters like Average weight, Hardness, Friability, Thickness, Diameter, Dissolution and Assay were as per specifications. All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly.


Cite this article:
Neha Sawant, Jawed Akhtar, Stavan Master. Studies in Con-Current Process Validation of Metformin Hydrochloride Tablet Dosage Form. Research J. Pharm. and Tech 6(7): July 2013; Page 718-725.


Recomonded Articles:

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): S.M. Charjan, S.K. Bais, R.R. Shiradkar, R.L. Bakal, V.M. Durge, A.V. Chandewar

DOI: Not Available         Access: Open Access Read More

Author(s): Hemlata M. Nimje, Rajesh J. Oswal, Sandip S. Kshirsagar, Manoj Chavan

DOI: Not Available         Access: Open Access Read More

Author(s): Jayesh M Jain, Dinesh M Sakarkar, Shajahan Abdul, Mangesh E Bhad, Anil V Chandewar and Sunil B Jaiswal

DOI: Not Available         Access: Closed Access Read More

Author(s): Rituraj Singh Chundawat, Y.S. Sarangdevot, R.P.S. Rathore, Dharmendra Singh Sisodiya, Udaibhan Singh Rathore

DOI:         Access: Open Access Read More

Author(s): V. Shirisha, Somsubhra Ghosh, B. Rajni, David Banji

DOI: Not Available         Access: Open Access Read More

Author(s): Kothawade PI, Zate SU, Gajbe JW, Rathi MN, Yewale CP, Baheti DR

DOI: Not Available         Access: Open Access Read More

Author(s): Mahaveer Singh, Gautam Singhvi, SG Kaskhedikar, Love soni

DOI: Not Available         Access: Open Access Read More

Author(s): B Srivastava, Uttam Singh Baghel, Pradeep Swarnkar and Shuchi Dave

DOI: Not Available         Access: Open Access Read More

Author(s): Prasada Rao CH , Seshagiri Rao JVLN, Dhachinamoorthi D, Lakshmi Aswini G, Ashok K

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags