Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION
DOI:
https://doi.org/10.22159/ajpcr.2019.v12i7.33938Keywords:
Dalfampridine,, Ultraviolet spectrophotometric,, Method development,, ValidationAbstract
Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency.
Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm.
Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims.
Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.
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References
Dunn J, Blight A. Dalfampridine: A brief review of its mechanism of action and efficacy as a treatment to improve walking in patients with multiple sclerosis. Curr Med Res Opin 2011;27:1415-23.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Vol. I. New Delhi: The Controller of Publication; 2014. p. 527.
Willard-Hobart H, Lynne LM Jr., John AD, Frank AS Jr. Instrumental Methods of Analysis. New Delhi: CBS Publishers and Distributors; 1988. p. 1-12, 580-10, 614-52.
Munson JW. In Pharmaceutical Analysis. Modern Methods. Mumbai: International Medical Book, Distributors; 2001. p. 28-32.
Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. 5th ed. New Delhi: Himalaya Publishing House; 2002. p. 566-87, 624-39.
Haque SK, Ahmad A. Development and validation of analytical method for quantification of acetic acid content in amlodipine besylate. Int J Pharm Pharm Sci 2019;11:8-11.
Swetha G, Kumar KP, Sirisha K. New validated method development for the estimation of sulfamethoxazole and trimethoprim in bulk form by visible spectroscopy. Int J Pharm Pharm Sci 2018;10:50-7.
Wasnik RN. Method development and validation of antineoplastic drug-imatinib by uv-spectroscopy. Indo Am J Pharm 2018;4:362-9.
Dashora K, Singh D, Saraf S. Validation-the essential quality assurance tool for pharmaceutical industries. Pharm Process Validation 2005;3:45-7.
Kaur M, Bhardwaj P, Kaur B, Sharma A, Karu C, Kumar R, et al. Development and validation of a novel stability indicating uv-spectrophotometric method for estimation of febuxostat in bulk and pharmaceutical formulation (tablets). Pharm Methods 2018;9:23-8.
Moharana A, Banerjee M. Development and validation of UV spectrophotometric method for the determination of mesalamine in bulk and tablet formulation. Int J Pharm Pharm Sci 2011;3:19-21.
Behera S, Ghanty S. UV-visible spectrophotometric method development and validation of assay of paracetamol tablet formulation. J Anal Bioanal Tech 2012;3:6.
Available from: https://www.drugs.com/monograph/dalfampridine. html.
Available from: https://www.pubchem.ncbi.nlm.nih.gov/compound/4- aminopyridine.
International Conference On Harmonization (Ich) Of Technical Requirements For The Registration Of Pharmaceuticals For Human Use. Ich-Q2(R1). Geneva: Validation of Analytical Procedures Methodology; 1996. p. 1-8.
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