Development and Validation of RP-HPLC Method for Estimation Safinamide in Its Bulk and Tablet Dosage Form

Authors

  • Pranali C. Baviskar
  • R. S. Bachhav

Keywords:

RP-HPLC, Safinamide, Parkinson’s disease, Development, Validation

Abstract

Background: This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining safinamide in bulk medication and tablet formulations. An HPLC method using a UV detector and the Openlab EZchrome workstation programme, as well as a Kromasil C18 (250 mm × 4.6 mm i.d.) 5 m, were used to separate the samples. At a flow rate of 1.0 mL/min, methanol and buffer (70:30 percent v/v) were pumped and measured at 226 nm. Result: The devised RP-HPLC method gave a satisfactory safinamide retention duration of 2.57 minutes, which was refined by trial and error. A correlation value (r2) of 0.99996 was used to confirm the linearity of the established method throughout a concentration range of 1.01–15.14 g/mL. The precision of the approach was determined to have a percentage RSD of less than 2.0 percent. The percentage recoveries were found to range between 99.60 and 100.80%. The LOD and LOQ were found to be 0.17 ug/mL and 0.52 ug/mL, respectively. Conclusion: The designed and validated RP-HPLC technology saves time and can be utilised in the industry for routine quality control and analysis of bulk drugs and commercialised safinamide products.

References

Yadav HP, Li Y. The development of treatment for Parkinson’s disease. Advances in Parkinson's Disease. 2015; 4 (03): 59.

Schapira AH. Monoamine oxidase B inhibitors for the treatment of Parkinson’s disease. CNS drugs. 2011; 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; 21 (2): 153–68.

Onofrj M, Bonanni L, Thomas A. An expert opinion on safinamide in Parkinson's disease. Expert opinion on investigational drugs. 2008; 17 (7): 1115–25.

Redasani VK, Mali BJ, Patil AS, Shirkhedkar AA. Development and validation of RP-HPLC method for determination of safinamide mesylate in bulk and in tablet dosage form. Analytical Chemistry an Indian Journal. 2013; 13 (4): 127–30.

Marzo A, Dal Bo L, Monti NC, Crivelli F, Ismaili S, Caccia C, Cattaneo C, Fariello RG. Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity. Pharmacological research. 2004; 50 (1): 77–85.

Deeks ED. Safinamide: first global approval. Drugs. 2015 Apr; 75 (6): 705–11.

El-Kosasy AM, Hussein LA, Mohamed NM, Salama NN. New and validated RP-HPLC Method for Quantification of Safinamide Mesylate in Presence of Its Basic Degradate, Levodopa and Ondansetron: Application to Human Plasma. Journal of Chromatographic Science. 2020; 58 (9): 789–95.

Malviya R, Bansal V, Pal OP, Sharma PK. High performance liquid chromatography: a short review. Journal of global pharma technology. 2010; 2 (5): 22–6.

Kazakevich YV, Lobrutto R. HPLC for pharmaceutical scientists. John Wiley & Sons; 2007 Feb 16.

LaboratoryInfo. (2022, Jan) High Performance Liquid Chromatography (HPLC): Principle, types, instrumentation and Applications. [Online] Available from https://laboratoryinfo.com/hplc/

LaCourse ME, LaCourse WR. General instrumentation in HPLC. InLiquid Chromatography 2017 Jan 1 (pp. 417–429). Elsevier.

Sabir, A.M. HPLC method development and validation-a review. International Research Journal of Pharmacy. 2013; 4 (4): 39–46.

Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry. 2017; 10: S3412–25.

International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use ich harmonized tripartite guideline validation of analytical procedures: text and methodology Q2(R1) Validation. Available online at: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf

Pendbhaje NS, Jamdhade AA, Pathan SM, Nirmal RV. A review on quantification of brexpiprazole in its bulk and pharmaceutical dosage form by various analytical methods. Int J Pharm Res Appl. 2021; 6 (1): 1118–32.

Vidushi Y, Meenakshi B. A review on HPLC method development and validation. Res J Life Sci, Bioinform, Pharm Chem Sci. 2017; 2 (6): 178.

Pendhbaje NS, Nirmal RV, Jamdhade AA, Pathan SM. Method development and validation by HPLC: a brief review. Research & Reviews: A Journal of Pharmaceutical Science. 2021; 12 (1): 27–39p.

Thammana M. A review on high performance liquid chromatography (HPLC). Research & Reviews: Journal of Pharmaceutical Analysis. 2016; 5 (2): 22–8p.

Kasture AV, Ramteke M. Simultaneous UV-spectrophotometric method for the estimation of atenolol and amlodipine besylate in combined dosage form. Indian journal of pharmaceutical sciences. 2006; 68 (3).

Barman RK, Islam MA, Ahmed M, Wahed MI, Islam R, Khan A, Hossain MB, Rahman BM. Simultaneous high-performance liquid chromatographic determination of atenolol and amlodipine in pharmaceutical-dosage form. Pak. J. Pharm. Sci. 2007; 20 (4): 274–9.

Downloads

Published

2022-03-23

Issue

Vol. 9 No. 1 (2022)

Section

Research Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.