Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2021
  • Volume: 14
  • Issue: 5

Stability indicating rp-hplc method development and validation for estimation of diroximel fumarate in bulk and its dosage forms

  • Author:
  • Ramachandrapuram Kiranjyothi1,*, Mahalingam Balakrishnan2, Kothapalli Bannoth Chandrasekhar3
  • Total Page Count: 5
  • Page Number: 2603 to 2607

1Department of Pharmaceutical Analysis and Quality Assurance, Research Scholar, Jawaharlal Nehru Technological University, Anantapur, Andhra Pradesh., India

2Department of Pharmacognosy, Sri Seshachala College of Pharmacy, Puttur Tirupati, Andhra PradeshIndia

3Vice Chancellor, Krishna University, Machillipatnam. Andhra Pradesh., India

*Corresponding Author E-mail: jyothikiran460@gmail.com

Online published on 25 August, 2021.

Abstract

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.

Chromatographic method was carried on Ci8 column (Waters 250mm x 4.6mm, 5|). 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 20 μL. The absorbance maxima of Diroximel Fumarate was measured at 215nm. The retention time was found to be 2.390 min.

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.

The developed method was simple, specific, precise, accurate and robust. The described HPLC method can be successfully employed for the analysis of Diroximel Fumarate.

Keywords

Diroximel Fumarate, RP-HPLC method, 85% OPA, Acetonitrile, Validation, ICH guidelines