Development of methods for qualitative analysis of Dixafen solution for injection

Митькина, Л. И.; Zaitseva, I. I.

doi:10.1007/bf00773170

Cited by 1 publication

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“…Various reports have been described for the analysis of EPH A good guide to the work published for EPH is found as comprehensive monograph in analytical profiles for drug substances [ 13 ]. Several techniques were reported for its determination including; titrimetry [ 14 ], spectrophotometry [ 15 ], fluorimetry [ 16 ], flow injection [ 17 ], capillary electrophoresis [ 18 ], TLC [ 19 ], HPLC [ 20 ], and gas chromatography [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

Spectrophotometric determination of certain CNS stimulants in dosage forms and spiked human urine via derivatization with 2,4-Dinitrofluorobenzene

Walash

El‐Enany

Saad

2011

Chemistry Central Journal

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A new spectrophotometric method is developed for the determination of phenylpropanolamine HCl (PPA), ephedrine HCl (EPH) and pseudoephedrine HCl (PSE) in pharmaceutical preparations and spiked human urine. The method involved heat-catalyzed derivatization of the three drugs with 2,4-dinitrofluorobenzene (DNFB) producing a yellow colored product peaking at 370 nm for PPA and 380 nm for EPH and PSE, respectively.The absorbance concentration plots were rectilinear over the range of 2-20 for PPA and 1-14 μg/mL for both of EPH and PSE, respectively. The limit of detection (LOD) values were 0.20, 0.13 and 0.20 μg/mL for PPA, EPH and PSE, respectively and limit of quantitation (LOQ) values of 0.60 and 0.40 and 0.59 μg/mL for PPA, EPH and PSE, respectively. The analytical performance of the method was fully validated and the results were satisfactory. The proposed method was successfully applied to the determination of the three studied drugs in their commercial dosage forms including tablets, capsules and ampoules with good percentage recoveries. The proposed method was further applied for the determination of PSE in spiked human urine with a mean percentage recovery of 108.17 ± 1.60 for (n = 3). Statistical comparison of the results obtained with those of the comparison methods showed good agreement and proved that there was no significant difference in the accuracy and precision between the two methods. The mechanism of the reaction pathway was postulated.

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