Method development and validation for the simultaneous determination of cetirizine dihydrochloride, paracetamol, and phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis
“…The solutions were completed to the required volume by the mobile phase and were subjected to the chromatographic analysis under optimum conditions. Calibration graphs were constructed by plotting area under the curve against drug concentration in μg/mL [6–8]. …”
Section: Methodsmentioning
confidence: 99%
“…The BP suggested a potentiometric titration method for determination of CTZ in its pure form; while it recommended an HPLC method for both cetirizine oral solution and tablets [2]. Different analytical procedures were reported for its determination including HPLC [3–6], HPTLC [7], capillary electrophoresis [8] and spectrophotometry [9]. Fig.…”
BackgroundThe combination between cetirizine (CET), phenylpropanolamine (PPA) and nimesulide (NMS) under trade name Nemeriv Cp tablet is prescribed for nasal congestion, cold, sneezing, and allergy. Among all published methods for the three drugs; there is no reported method concerning estimation of CTZ, PPA and NMS simultaneously and this motivates us to develop new and simple methods for their assay in pure form and tablet preparations.ResultsTwo new methodologies were described for the simultaneous quantification of cetirizine (CTZ), PPA and NMS. Spectrophotometric procedures relies on measuring the amplitudes of the third derivative curves at 238 nm for CTZ, 218 nm for PPA and 305 nm for NMS. The calibration graphs were rectilinear over the ranges of 8–90 µg/mL for CTZ, 20–100 µg/mL for PPA and 20–200 µg/mL for NMS respectively. Regarding the HPLC method; monolithic column (100 mm × 4.6 mm i.d) was used for the separation. The used mobile phase composed of 0.1 M phosphate buffer and methanol in the ratio of 40:60, v/v at pH 7.0. The analysis was performed using UV detector at 215 nm. Calibration curves showed the linearity over concentration ranges of 5–40, 10–100 and 10–120 µg/mL for CTZ, PPA and NMS.ConclusionApplication of the proposed methods to the laboratory prepared tablets was carried out successfully. The results were compared with those obtained from previously published methods and they were satisfactory.Graphical abstractGraphical abstract represents the chemical structures, representative chromatogram for the HPLC separation of a PPA, b NMS and c CTZ and third derivative absorption spectra of a PPA, b NMS and c CTZ for the spectrophotometric method.
“…The solutions were completed to the required volume by the mobile phase and were subjected to the chromatographic analysis under optimum conditions. Calibration graphs were constructed by plotting area under the curve against drug concentration in μg/mL [6–8]. …”
Section: Methodsmentioning
confidence: 99%
“…The BP suggested a potentiometric titration method for determination of CTZ in its pure form; while it recommended an HPLC method for both cetirizine oral solution and tablets [2]. Different analytical procedures were reported for its determination including HPLC [3–6], HPTLC [7], capillary electrophoresis [8] and spectrophotometry [9]. Fig.…”
BackgroundThe combination between cetirizine (CET), phenylpropanolamine (PPA) and nimesulide (NMS) under trade name Nemeriv Cp tablet is prescribed for nasal congestion, cold, sneezing, and allergy. Among all published methods for the three drugs; there is no reported method concerning estimation of CTZ, PPA and NMS simultaneously and this motivates us to develop new and simple methods for their assay in pure form and tablet preparations.ResultsTwo new methodologies were described for the simultaneous quantification of cetirizine (CTZ), PPA and NMS. Spectrophotometric procedures relies on measuring the amplitudes of the third derivative curves at 238 nm for CTZ, 218 nm for PPA and 305 nm for NMS. The calibration graphs were rectilinear over the ranges of 8–90 µg/mL for CTZ, 20–100 µg/mL for PPA and 20–200 µg/mL for NMS respectively. Regarding the HPLC method; monolithic column (100 mm × 4.6 mm i.d) was used for the separation. The used mobile phase composed of 0.1 M phosphate buffer and methanol in the ratio of 40:60, v/v at pH 7.0. The analysis was performed using UV detector at 215 nm. Calibration curves showed the linearity over concentration ranges of 5–40, 10–100 and 10–120 µg/mL for CTZ, PPA and NMS.ConclusionApplication of the proposed methods to the laboratory prepared tablets was carried out successfully. The results were compared with those obtained from previously published methods and they were satisfactory.Graphical abstractGraphical abstract represents the chemical structures, representative chromatogram for the HPLC separation of a PPA, b NMS and c CTZ and third derivative absorption spectra of a PPA, b NMS and c CTZ for the spectrophotometric method.
“…A good guide to the work published is found as comprehensive monograph in analytical profiles for drugs [4]. Several analytical techniques have been reported for PPA determination either perse or in pharmaceutical preparations and biological fluids including; titrimetry [5], spectrophotometry [6], fluorimetry [7], HPLC [8], capillary electrophoresis [9], flow injection [10] and gas chromatography [11]. …”
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.
“…26 These compensations empower CE with great utility to be successfully applied for routine pharmaceutical analysis. 25 CE methods, using different detection wavelengths and buffer systems, are available in the literature for determination of CTZ in syrup and tablets 27,28 or combinated in multicomponent dosage form, 29 as well as in its chiral separation in pharmaceuticals. [30][31][32] In this paper, we propose develop and validate a CE method for determination of CTZ in tablets and compounded capsules according to official guidance requirements for industry.…”
Recebido em 13/2/09; aceito em 21/7/09; publicado na web em 25/11/09 A capillary electrophoresis (CE) method was developed and validated for determination of cetirizine dihydrochloride in tablets and compounded capsules. The electrophoretic separation was performed in an uncoated fused-silica capillary (40 cm x 50 μm i.d.) using 20 mmol L -1 sodium tetraborate buffer (pH 9.3) as background electrolyte, a hydrodinamic sample injection at 50 mBar for 5 s, 20 KV applied voltage at 25 °C, and detection at 232 nm. The proposed method was compared with the high performance liquid chromatographic (HPLC) method previously validated for this drug, and statistical analysis showed no significant difference between the techniques.
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