Validation of UV Spectrophotometric Method for Fexofenadine Hydrochloride in Pharmaceutical Formulations and Comparison with HPLC

Breier, Ana Rita; Steppe, Martin; Schapoval, Elfrides E.S.

doi:10.1080/00032710701576023

Cited by 16 publications

(14 citation statements)

References 13 publications

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“…For that, different fexofenadine solutions their pH values range (2-6) were prepared, the potential was measured for each solution using FEX.Mol graphite sensor, we found that the potential stay stable between pH range (2.5-4.5), at pH value more than 4.5 a noticed decrease in potential was found. For MON.Co sensor, different Montelukast solutions their pH values range (3)(4)(5)(6)(7)(8)(9)(10)(11) were prepared, and the potential was measured for each solution using MON.Co sensor, the effective pH range was found to be (5-9.5), at pH values less than 5, Montelukast drug participated, and more than 9.5 there was a decrease in the measured potential. It was found that there is no requirement for using any buffer, as buffers may involve some obtrusive substances, and because of the wide range of pH for both sensors (I and II).…”

Section: Effect Of Phmentioning

confidence: 99%

Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form

Nashed¹,

Noureldin²,

Sakur³

2020

Preprint

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This paper introduces a new electrochemical approach for the concomitant determination of fexofenadine hydrochloride and montelukast sodium by constructing three new graphite electrodes coated with a polymeric membrane. The first electrode was constructed using ammonium molybdate reagent as an ion pair with fexofenadine cation for the determination of fexofenadine drug, the second electrode was constructed using cobalt nitrate as an ion pair with montelukast anion for the determination of montelukast drug, the third electrode was prepared by incorporating the two previously mention ion pairs in the same graphite sensor, which make this sensor sensitive to each fexofenadine and montelukast drug. The coating material was a polymeric film comprises of Poly Vinyl Chloride (PVC), Di-butyl phthalate as a plasticizer (DBP), ion pairs of drugs with previously mentioned reagents. The electrodes showed a Nernstian response with a mean calibration graph slopes of [58.97, 28.43, (59.048 , 28,643 )] mv.decade-1 for the three pencil electrodes respectively. The electrodes work effectively over pH range (2-4.5) for fexofenadine hydrochloride and (5-9.5) for montelukast sodium. The influence of the proposed interfering species was negligible. The effectiveness of the electrodes continued in a period of time (45-69) days. The suggested sensors demonstrated useful analytical features for the determination of both drugs in bulk powder, in laboratory prepared mixtures and their combined dosage form. We have validated the method in accordance with ICH protocol.

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Section: Effect Of Phmentioning

confidence: 99%

Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form

Nashed¹,

Noureldin²,

Sakur³

2020

Preprint

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“…The results presented in Table 6 showed that the methods are successful to the determination of FFH in pharmaceutical formulations without any detectable interference from the excipients present in the tablets. The reference method describes the measurement of the absorbance of ethanolic solution of FFH at 220 nm [19]. When the results were statistically compared with those of the reference method by applying the Student's t-test for accuracy and F-test for precision, the calculated Student's t-value and Fvalue at 95% confidence level did not exceed the tabulated values of 2.78 and 6.39, respectively.…”

Section: Application To Analysis Of Tabletsmentioning

confidence: 99%

“…Literature survey revealed the availability of few methods for the assay of FFH in pharmaceuticals. Quantification of FFH has been achieved by high performance liquid chromatography (HPLC) [4][5][6][7][8][9][10][11][12][13], spectrofluorimetry [14], capillary electrophoresis [15], cyclic voltammetry [16], and UV spectrophotometry [17][18][19]. Direct potentiometric and potentiometric titrations methods employing polymeric membrane sensors were developed by Abbas et al; the titrimetric method involved potentiometric titration of the drug with phosphomolybdic acid, and membrane sensors were used for end-point detection [20].…”

Section: Introductionmentioning

confidence: 99%

Use of Alizarin Red S as an Ion-Pair Reagent for the Spectrophotometric Assay of Fexofenadine in Pharmaceuticals and in Spiked Human Urine

et al. 2012

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The present study describes two simple, rapid, selective, and cost-effective spectrophotometric methods for the determination of an antiallergic drug, fexofenadine hydrochloride (FFH), in bulk drug, tablets, and in spiked human urine. The first method (method A) is based on the formation of yellow-colored ion-pair complex between FFH and alizarin red S (AZS) in acid medium which was extracted into dichloromethane, and the absorbance was measured at 440 nm. The second method (method B) is based on the breaking of the yellow FFH-AZS ion-pair complex in alkaline medium followed by the measurement of the violet-colored free dye at 590 nm. Under the optimized conditions, Beer's law is obeyed over the concentration ranges of 0.4-12.0 and 0.2-3.5 μg mL −1 FFH for method A and method B, respectively, and the corresponding molar absorptivity values are 3.80 × 10 4 and 1.61 × 10 5 L mol −1 cm −1 . The Sandell's sensitivity, detection, and quantification limits are also reported. The proposed methods were successfully applied to the determination of FFH in pure drug and commercial tablets. The accuracy and reliability of the proposed methods were further established by recovery studies via standard addition technique.

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“…[13][14][15] Few methods were reported for the determination of FXN using spectrophotometric method. [16,17] One of the methods found in the literature that was developed for simultaneous detection of FXN and its related compounds, expanded the analysis to only two structural impurities of FXN by high performance liquid chromatography [18] and a recently reported method was developed for the determination and separation of FXN and its structural impurities using ion-pair chromatography. [19] There are also some reported capillary electrophoretic methods in literature for determination of FXN.…”

Section: Introductionmentioning

confidence: 99%

Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

Javid

Shafaati

Zarghi

2013

Journal of Liquid Chromatography & Related Technologies

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& A reversed-polarity capillary electrophoretic method based on application of sodium dodecyl sulfate (SDS) micelles as the carriers was developed for separation and determination of Fexofenadine (FXN) hydrochloride and its three major structural impurities in bulk and a tablet dosage form. CE analysis was performed using untreated fused-silica capillary of 50 lm internal diameter and 75-cm total length (25-cm effective length). The voltage applied of À25 kV at 25 C, and the detection wavelength was set at 225 nm. The running buffer was a 150 mM phosphate buffer at pH ¼ 3.0, containing 22 % v=v acetonitrile and 25 mmol SDS. Terfenadine was used as the internal standard (IS). The proposed method was found selective for determination of the main drug and its major impurities. The limit of quantification (LOQ) for FXN and impurities D10, D11, and A were found 70 lg=mL, 50 lg=mL, 80 lg=mL, and 100 lg=mL, respectively. The regression data obtained from the calibration plots indicated linear relationship (r 2 ¼ 0.997) over the concentration range of 70-500 lg=mL of FXN. Repeatability and reproducibility of the method, assessed as intra-day and inter-day variation and expressed as RSD ( %), were less than 4 % for relative peak area. Then, the method was applied for the determination of FXN in bulk and a tablet dosage form.

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Validation of UV Spectrophotometric Method for Fexofenadine Hydrochloride in Pharmaceutical Formulations and Comparison with HPLC

Cited by 16 publications

References 13 publications

Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form

Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form

Use of Alizarin Red S as an Ion-Pair Reagent for the Spectrophotometric Assay of Fexofenadine in Pharmaceuticals and in Spiked Human Urine

Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

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