Author(s): Vishnu Vardhana Rao. G, V. Srinivasa Rao, K. Ramakrishna

Email(s): karipeddirk@gmail.com

DOI: 10.5958/0974-360X.2015.00266.8   

Address: Vishnu Vardhana Rao. G1, V. Srinivasa Rao2, K. Ramakrishna1*
1Department of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatman, India
2Analytical Research and Development, Syngene International Ltd, Biocon Park, Bommasandra Industrial Estate, Bangalore, India
*Corresponding Author

Published In:   Volume - 8,      Issue - 11,     Year - 2015


ABSTRACT:
The present study describes the quality by design based approach for the development and validation of LC method for the estimation in-vitro release of Raloxifene (RXF) hydrochloride in formulation dosage. The development activity is conducted by the HPLC technique with the UV detector. Validation activity is planned and completed based on the International Conference on Harmonization (ICH) guidelines. The method uses an Inertsil ODS 3V 150x 4.6, 5.0 µm HPLC column with a mobile phase consisting 500 mL of buffer (0.1% Trifluoro acetic acid) and 500 mL Methanol. The UV detector set at 287 nm. All the experiments are carried out at column temperature 350 C column oven temperatures with 1.0ml/min flow rate. The method was validated for specificity, linearity, accuracy, precision and robustness. Robustness had established, to estimate the impact of minor changes in evaluation parameters. Design expert was applied, and a 23 full factorial design was used to observe the influence of factors in robustness study.


Cite this article:
Vishnu Vardhana Rao. G, V. Srinivasa Rao, K. Ramakrishna. Quality by Design Approach for the Development and Validation of LC method for the Estimation of in-Vitro release of Raloxifene hydrochloride in Dosage Formulation. Research J. Pharm. and Tech. 8(11): Nov., 2015; Page 1487-1494. doi: 10.5958/0974-360X.2015.00266.8


Recomonded Articles:

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Jino Elsa Thomas, Usha Y Nayak*, Jagadish PC, Koteshwara KB

DOI: 10.5958/0974-360X.2017.00007.5         Access: Open Access Read More

Author(s): Sonte Sushmitha, Sedimbi Revathi Priyanka, L. Mohan Krishna, M. Srinavasa Murthy

DOI: Not Available         Access: Open Access Read More

Author(s): Mistry Khushboo, Kavya Naik, Vasanthi, Alicia Menezes, Anup Naha, K.B. Koteshwara, K. Girish Pai

DOI: 10.5958/0974-360X.2017.00540.6         Access: Open Access Read More

Author(s): Deepak Karki, Gururaj S. Kulkarni, Shivakumar Swamy, Sheeba FR

DOI: 10.5958/0974-360X.2017.00750.8         Access: Open Access Read More

Author(s): Praveen D, Ranadheer Chowdary P, Gandikota Thanmayi, Gangabathina Poojitha, Vijey Aanandhi M

DOI: 0.5958/0974-360X.2016.00047.0         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): Avinash Bhagwat, Suhas M Kakade, Chirag V Naval, Mukesh Tilker, Ravindra M Walture, Sagar A Adichwal and Atul P Chaudhari

DOI: Not Available         Access: Open Access Read More

Author(s): Rekha Kallam, Padma Sree K, Srinivas Arutla, MA Bari

DOI: Not Available         Access: Open Access Read More

Author(s): Ravi K. Barde, Minal R. Narkhede, V.R. Gudsoorkar, Rahul K. Amrutkar, Prashant S. Walke

DOI: Not Available         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Katare Varsha B., Bhutkar M. A., Kumbhar A. P., Pol S. K., Katare P. B.

DOI: Not Available         Access: Open Access Read More

Author(s): Mohd Yousuf Ali, Md Shamim Qureshi, Md Hamed, Byasabhusan Das and K Purushotham Rao

DOI: Not Available         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         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