Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

  • VAIBHAV S KHODKE Department of Quality Assurance, Vidyabharati College of Pharmacy, Amravati, Maharashtra, India.
  • GAME MD Department of Quality Assurance, Vidyabharati College of Pharmacy, Amravati, Maharashtra, India.

Abstract

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.

Keywords: Dalfampridine,, Ultraviolet spectrophotometric,, Method development,, Validation.

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VAIBHAV S KHODKE, and GAME MD. “Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 7, May 2019, pp. 275-9, https://innovareacademics.in/journals/index.php/ajpcr/article/view/33938.
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