Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms

Hadad, Ghada M.; Emara, Samy; Mahmoud, Waleed M. M.

doi:10.1016/j.talanta.2009.06.003

Cited by 88 publications

(45 citation statements)

References 22 publications

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“…The average percentages found of different concentrations were based on the average of three replicate determinations. The results shown in Table V are in good agreement with the comparison methods [10,13]. …”

Section: Pharmaceutical Applications Dosage Forms Analysissupporting

confidence: 80%

“…For better understanding of the typical factors which govern the retention, a complementary set of experiments as fold-over design was performed (Table II, experiments [13][14][15][16][17][18][19][20]. This represents a fold-over of the previous design and is obtained by changing the sign of the three last columns of the fractional design.…”

Section: Fold-over Fractional Factorial Designmentioning

confidence: 99%

“…The accuracy of the proposed method was evaluated by analyzing standard solutions of the studied drugs. The results obtained by the proposed method were favorably compared with those obtained by the comparison method [13].…”

Section: Accuracymentioning

confidence: 99%

“…Even the only reported method for their simultaneous determination [13] applied a tedious and complicated gradient elution with relatively expensive solvents. Therefore, the present study was involved in a research effort aimed at developing and validating a simple, selective, and accurate new micellar liquid chromatographic method for the simultaneous determination of CTZ, PSU, and PCA in their combined dosage form and in biological fluids.…”

Section: Introductionmentioning

confidence: 99%

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Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

El-Din¹,

Ibrahim²,

Eid³

et al. 2013

Acta Chromatographica

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Abstract. An accurate, simple, sensitive, and selective micellar liquid chromatographic method has been developed for the simultaneous determination of cetirizine dihydrochloride in two of its combined pharmaceutical preparations with psudoephedrine hydrochloride and/or paracetamol. The chemometrics approach was applied for the optimization of separation of the studied drugs to optimize their separation; the effect of six experimental parameters on retention was investigated by means of multivariate analysis. Separation was conducted using an ODS C18 (150 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 250 nm. A mobile phase composed of 0.135 M sodium dodecyl sulphate, 11% 1-propanol, 0.3% tri-ethylamine in 0.02 M phosphoric acid, and adjusted to pH 3.3 has been used at a flow rate of 1 mL/min. Regression models were characterized by both descriptive and predictive ability (R 2 ≥ 98.8% and R 2 cv ≥ 94.5%) and allowed the chromatographic separation of the drugs with a good resolution and a total analysis time within 6 min.The calibration curves were rectilinear over the concentration ranges of 0.05-1.0, 0.07-4.0, and 1.0-10.0 μg/mL for cetirizine dihydrochloride, psudoephedrine hydrochloride, and paracetamol respectively; with detection limits of 0.01, 0.05, and 0.08 μg/mL, and quantification limits of 0.04, 0.09, and 1.02 μg/mL, respectively. The results obtained were in good agreement with those obtained by the comparison method. Furthermore, the method was applied for the determination of the drugs in spiked human plasma and used to reveal the pharmacokinetic characters in a healthy volunteer treated with oral administration of the studied two combined dosage forms of cetirizine.

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Section: Pharmaceutical Applications Dosage Forms Analysissupporting

confidence: 80%

Section: Fold-over Fractional Factorial Designmentioning

confidence: 99%

Section: Accuracymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

El-Din¹,

Ibrahim²,

Eid³

et al. 2013

Acta Chromatographica

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“…DAS was also determined either alone [13] or in presence of its metabolites and impurities [14,15] or in biological fluids [16,17]. Literature search revealed only one high performance liquid chromatographic method with UV detection (HPLC-UV) for the simultaneous determination of PAR and DAS in dosage form [18]. Thus, the aim of this work was to develop and validate spectrophotometric methods for the determination of PAR and DAS in combination without sample pretreatment.…”

Section: Paracetamol (Par); N-acetyl-p-aminophenol;mentioning

confidence: 99%

Spectrophotometric methods for the simultaneous determination of paracetamol and dantrolene sodium in pharmaceutical dosage form

et al. 2014

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KEYWORDSAccurate, precise and simple spectrophotometric methods have been developed and validated for the determination of paracetamol (PAR) and dantrolene sodium (DAS). Spectrophotometric methods including zero order, first derivative ( 1 D) and derivative ratio methods ( 1 DD) have been developed. The zero order spectrophotometric method was used for the determination of DAS in the range of 1-20 μg/mL by measuring the absorbance at 379 nm where PAR exhibits zero reading. 1 D and 1 DD methods were used for the determination of PAR in the range of 1.5-20.0 μg/mL by measuring the peaks amplitudes at 265.5 nm and 265.0 nm, respectively. The proposed methods were used to determine PAR in binary mixture with DAS in the laboratory prepared mixtures and in pharmaceutical dosage form. The results obtained were statistically evaluated and found to be accurate and precise and can be satisfactorily applied for the quality control analysis of the cited drugs.

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A novel spectrofluorimetric method for the assay of pseudoephedrine hydrochloride in pharmaceutical formulations via derivatization with 4‐chloro‐7‐nitrobenzofurazan

El‐Didamony

Gouda

2010

Luminescence

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A new highly sensitive and specific spectrofluorimetric method has been developed to determine a sympathomimetic drug pseudoephedrine hydrochloride. The present method was based on derivatization with 4-chloro-7-nitrobenzofurazan in phosphate buffer at pH 7.8 to produce a highly fluorescent product which was measured at 532 nm (excitation at 475 nm). Under the optimized conditions a linear relationship and good correlation was found between the fluorescence intensity and pseudoephedrine hydrochloride concentration in the range of 0.5-5 µg mL(-1). The proposed method was successfully applied to the assay of pseudoephedrine hydrochloride in commercial pharmaceutical formulations with good accuracy and precision and without interferences from common additives. Statistical comparison of the results with a well-established method showed excellent agreement and proved that there was no significant difference in the accuracy and precision. The stoichiometry of the reaction was determined and the reaction pathway was postulated.

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Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms

Cited by 88 publications

References 22 publications

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Spectrophotometric methods for the simultaneous determination of paracetamol and dantrolene sodium in pharmaceutical dosage form

A novel spectrofluorimetric method for the assay of pseudoephedrine hydrochloride in pharmaceutical formulations via derivatization with 4‐chloro‐7‐nitrobenzofurazan

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