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

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.

Application of spectrophotometric methods for estimation of Mebendazole in tablet formulation

“…A precision of the proposed method is performed to check the degree of repeatability of the method. In this method, the sample is measured at least three times on the same day at intervals of an hour for an inter-day study and three different days for inter-day study (Khodke, 2019). The standard deviation (SD) and relative standard deviation (RSD) were calculated.…”

“…For this study six replicates of the analyte at the lowest concentration were measured and quantified. LOD measures the limit of the method to detect the minimum concentration of an analyte in the sample; however undoubtedly quantitated as an exact value (Chanda et al, 2017;Khodke, 2019;Narang, 2018). The LOQ may be defined as the limit of minimum detection capacity of the method to analyze the analyte in a sample which shows the quantitated reliably with the specified level of accuracy and precision (Shrivastav et al, 2020).…”