Author(s): Rama chandrapuram Kiranjyothi, Mahalingam Balakrishnan, Kothapalli Bannoth Chandrasekhar

Email(s): jyothikiran460@gmail.com

DOI: 10.52711/0974-360X.2021.00458   

Address: Rama chandrapuram Kiranjyothi1*, Mahalingam Balakrishnan2, Kothapalli Bannoth Chandrasekhar3
1Department of Pharmaceutical Analysis and Quality Assurance, Research Scholar,
Jawaharlal Nehru Technological University, Ananthapuramu, Andhra Pradesh., India.
2Department of Pharmacognosy, Sri Seshachala College of Pharmacy, Puttur Tirupati, Andhra Pradesh India.
3Vice Chancellor, Krishna University, Machillipatnam. Andhra Pradesh., India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 5,     Year - 2021


ABSTRACT:
Aim and objective: The aim of present research work is to develop validated RP-HPLC stability indicating method for the quantification of Diroximel Fumarate in bulk and its pharmaceutical dosage forms. Materials and methods: Chromatographic method was carried on C18 column (Waters 250mm x 4.6mm, 5m). Mobile phase was prepared by mixing water: Acetonitrile: 85% OPA: in the ratio of 70:30. The flow rate was 0.1 mL/min and the injection volume was 20µL. The absorbance maxima of Diroximel Fumarate was measured at 215nm. The retention time was found to be 2.390 min. Result: The method was proved to be specific and linear in the range of 50-150µg/mL with correlation coefficient of 0.999. The % RSD for precision was found to be less than 2% and the mean percentage recovery was 100.15%. All the validation parameters were statistically validated according to ICH guidelines and were found to be within acceptance criteria. Conclusion: The developed method was simple, specific, precise, accurate and robust. The described HPLC method can be successfully employed for the analysis of Diroximel Fumarate.


Cite this article:
Rama chandrapuram Kiranjyothi, Mahalingam Balakrishnan, Kothapalli Bannoth Chandrasekhar. Stability Indicating RP-HPLC Method Development and Validation for Estimation of Diroximel Fumarate in bulk and its dosage forms. Research Journal of Pharmacy and Technology. 2021; 14(5):2603-7. doi: 10.52711/0974-360X.2021.00458

Cite(Electronic):
Rama chandrapuram Kiranjyothi, Mahalingam Balakrishnan, Kothapalli Bannoth Chandrasekhar. Stability Indicating RP-HPLC Method Development and Validation for Estimation of Diroximel Fumarate in bulk and its dosage forms. Research Journal of Pharmacy and Technology. 2021; 14(5):2603-7. doi: 10.52711/0974-360X.2021.00458   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-5-42


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