RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Fexofenadine Hydrochloride in bulk and in a Tablet Mixture

Buchupalli, Prathyusha; Srinivas, Medidi

doi:10.7324/japs.2015.50211

Cited by 2 publications

(1 citation statement)

References 9 publications

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“…Various ultraviolet (UV) and high-performance liquid chromatographic (HPLC) assay methods are also reported in literature for the estimation of phenylephrine and fexofenadine individually and in combination with other drugs [7][8][9][10][11][12]. According to literature survey, there is no official method for the simultaneous estimation of phenylephrine and fexofenadine by reverse phase-HPLC (RP-HPLC) in combined tablet dosage forms.…”

Section: Fexofenadine Is Chemically Named As 2-(4-{1-hydroxy-4-[4(hydmentioning

confidence: 99%

A Stability-Indicating and Validated Reverse-Phase High-Performance Liquid Chromatographic Method for the Simultaneous Estimation of Phenylephrine and Fexofenadine in Bulk and Tablet Dosage Forms

Kumar¹,

Jyothi²,

B³

2016

Asian J Pharm Clin Res

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Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.Methods: Chromatography was carried out on an Kromasil C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of ortho phosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the detection was carried out using a photodiode array detector at 210 nm. Results:The retention times for phenylephrine and fexofenadine were 2.156 minutes and 3.359 minutes, respectively. The percentage recoveries of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be <2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine, respectively. Conclusion:Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.

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Section: Fexofenadine Is Chemically Named As 2-(4-{1-hydroxy-4-[4(hydmentioning

confidence: 99%

A Stability-Indicating and Validated Reverse-Phase High-Performance Liquid Chromatographic Method for the Simultaneous Estimation of Phenylephrine and Fexofenadine in Bulk and Tablet Dosage Forms

Kumar¹,

Jyothi²,

B³

2016

Asian J Pharm Clin Res

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A Validated High Performance Liquid Chromatography Method for the Simultaneous Analysis of Guaifenesin, Ambroxol and Loratidine in Bulk and Liquid Dosage form

Sailaja¹,

Babu²

2015

J App Pharm Sci

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A simple and sensitive HPLC method for simultaneous quantification of guaifenesin, ambroxol and loratidine in bulk and liquid dosage form was developed and fully validated. The separation and quantification was performed using a Kromasil C8 (250 × 4.6 mm, particles 5 μm) HPLC column. Isocratic elution mode with a flow rate of 1.2 mL/min was used, and the injection volume was 10 µL. The detector was set to a wavelength of 290 nm and the column oven was maintained at 30 °C. Orthophosphoric acid (0.1%) and acetonitrile in the ratio of 60:40 v/v was used as the mobile phase. Guaifenesin, ambroxol and loratidine were eluted with retention time of 3.045 min, 5.489 min and 13.981 min, respectively. The method was validated in accordance with ICH guidelines and the results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 50-150 µg/mL, 30-90 µg/mL and 5-15 µg/mL for guaifenesin, ambroxol and loratidine, respectively. Developed method was successfully applied for the quantification of the above three drugs in liquid dosage form. The excipient did not interfere with drug peaks.

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RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Fexofenadine Hydrochloride in bulk and in a Tablet Mixture

Cited by 2 publications

References 9 publications

A Stability-Indicating and Validated Reverse-Phase High-Performance Liquid Chromatographic Method for the Simultaneous Estimation of Phenylephrine and Fexofenadine in Bulk and Tablet Dosage Forms

A Stability-Indicating and Validated Reverse-Phase High-Performance Liquid Chromatographic Method for the Simultaneous Estimation of Phenylephrine and Fexofenadine in Bulk and Tablet Dosage Forms

A Validated High Performance Liquid Chromatography Method for the Simultaneous Analysis of Guaifenesin, Ambroxol and Loratidine in Bulk and Liquid Dosage form

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