Analytical Method Development And Validation Of Rp-Hplc Method For Estimation Of Safinamide In Bulk And Pharmaceutical Dosage Form.
Keywords:
Safinamide, Development and validation, RP-HPLC, Accuracy, PrecisionAbstract
Background: A rapid, highly sensitive, high-performance liquid chromatographic method has been developed to determine safinamide in bulk drug and pharmaceutical dosage form. The separation was performed using an HPLC method with a UV Openlab EZ Chrome workstation program, as well as a Kromasil 100 C18 (125 mm X 4.0 mm i.d.) 5 µm. 0.2 % OPA and methanol (65:35 v/v) were pumped at a flow rate of 1.0 mL/min and detected at 226 nm.
Result: The developed RP-HPLC method yielded a suitable retention time for safinamide of about 3.7 minutes, which was optimized on a trial-and-error basis. The linear response correlation coefficient (r² = 1.0000) was observed in the range of 20- 60µg/ml. The percentage RSD for the method's precision was found to be less than 2.0 percent. Validation parameters such as specificity, accuracy, linearity, precision, and robustness were also determined.
Conclusion: The developed and validated RP-HPLC system can be used in the industry for routine quality control/analysis of bulk drug and marketed safinamide products..
Downloads
References
Yadav HP, Li Y. The development of treatment for Parkinson’s disease. Advances in Parkinson's Disease. 2015 Jul 23;4(3):59-78.
Schapira AH. Monoamine oxidase B inhibitors for the treatment of Parkinson’s disease: a review of symptomatic and potential disease-modifying effects. CNS drugs. 2011 Dec;25(12):1061-71.
Blandini F, Armentero MT. New pharmacological avenues for the treatment of L-DOPA-induced dyskinesias in Parkinson's disease: targeting glutamate and adenosine receptors. Expert opinion on investigational drugs. 2012 Feb 1;21(2):153-68.
Shirisha v, srikanth g, santhosh illendula dk. Rp-hplc method development and validation for the estimation of safinamide in api form and marketed formulation.
Rehman A, Tiwari PN, Rao S. Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022;12(3):173-8.
Amrutkar GR, Aher SS, Bachhav RS. Stability indicating RPHPLC method development and validation for estimation of Safinamide in bulk drug and dosage form. International Journal of Pharmacy and Biological Sciences. 2022;12(4):2321-3272.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
