Stability Studies of Over the Counter Quaternary Mixture Containing Phenylephrine Hydrochloride, Chlorpheniramine Maleate, Paracetamol and Caffeine Using Different Chromatographic Methods

Ragab, Marwa A.A.; Yazbi, Fawzy A. El; Hassan, Ekram M.; Khamis, E.; Hamdy, Mohamed M.A.

doi:10.1080/22297928.2018.1438314

Cited by 6 publications

(8 citation statements)

References 15 publications

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“…Acceptable peak stability of the easily hydrolyzable RDV, while maintaining good resolution, peak symmetry, and reasonable analysis time, was mainly achieved. Thus, different parameters were studied by running the degraded samples using variable conditions (Maggio, Vignaduzzo, & Kaufman, 2013;Ragab, El Yazbi, Hassan, Khamis, & Hamdy, 2018).…”

Section: Resultsmentioning

confidence: 99%

Accelerated stability study of the ester prodrug remdesivir: Recently FDA‐approved Covid‐19 antiviral using reversed‐phase‐HPLC with fluorimetric and diode array detection

Hamdy

Moneim

Kamal

2021

Biomedical Chromatography

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Remdesivir (RDV) is the first antiviral drug, approved by the Food and Drug Administration, to treat severe acute respiratory syndrome coronavirus 2. RDV is a relatively new chemical entity, 'ester prodrug', with no reported stability profile.Due to the urgency of its use and thus fast production, it is important to develop a stability-indicating method for its assay. Chromatographic separation was carried out on a C18 column (250 Â 4.6 mm, 5 μm) with dual detection: diode array at 240 nm and fluorescence at λ ex/em 245/390 nm. Isocratic elution of acetonitrile and distilled water (acidified with phosphoric acid, pH 4) in the ratio of 55:45 (v/v), respectively, was used. The linearity range using HPLC-diode array detection was 0.1-15 μg/mL, whereas that using fluorimetric detection was 0.05-15 μg/mL. As per the International Conference on Harmonization guidelines, RDV has been degraded by accelerated alkaline, acidic, neutral hydrolysis, oxidative, heat, and photolytic stress conditions. Possible degradation hypothesis of the parent molecule has been suggested and illustrated. The proposed methods have achieved selective determination of the intact drug with no peaks overlapping in all assumptions. Extensive degradation confirms threatened drug stability at thermal and basic hydrolytic stressing. The developed methods were fully validated and proved suitable for quality control routine analysis of RDV in raw material and pharmaceutical dosage forms.

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Section: Resultsmentioning

confidence: 99%

Accelerated stability study of the ester prodrug remdesivir: Recently FDA‐approved Covid‐19 antiviral using reversed‐phase‐HPLC with fluorimetric and diode array detection

Hamdy

Moneim

Kamal

2021

Biomedical Chromatography

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“…The possible degradation pathways and products of PHE and IBU were studied at similar stress conditions for developing eco-friendly HPLC stability indicating method for assay of the binary mixture of PHE and IBU. PHE was reported to be more stable toward acidic, alkaline, and thermal conditions [ 19 – 22 ] but more susceptible to oxidative conditions producing two degradation products [ 20 ]. IBU was reported to be susceptible only to strong oxidative and thermal degradation [ 23 – 25 ].…”

Section: Resultsmentioning

confidence: 99%

“…Literature survey revealed that few techniques are available for quantification of PHE and IBU simultaneously in their binary combination such as spectrophotometry [ 15 ], spectrofluorimetry [ 16 ] and HPLC [ 17 , 18 ]. The two drugs were subjected to stability studies in their mixtures with other drugs [ 19 – 25 ], but no method was developed for the stability indicating assay of this binary mixture. IBU was susceptible only to strong oxidative and thermal degradation [ 23 – 25 ].…”

Section: Introductionmentioning

confidence: 99%

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Development of an eco-friendly HPLC method for the stability indicating assay of binary mixture of ibuprofen and phenylephrine

Kelani,

Fayez,

Abdel-Raoof

et al. 2023

BMC Chemistry

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The development and validation of the stability indicating HPLC technique has contributed to the understanding of the stability profile of ibuprofen (IBU) and phenylephrine (PHE). Stability profile was achieved for PHE; the drug was found to be liable to be influenced by stress oxidative conditions; two oxidative degradants (Deg1 & Deg2) were formed and their structures were confirmed using IR and mass spectrometry. The drugs and degradation products were successfully separated using a gradient elution method on YMC-C8 column with 0.1% hexanesulfonic acid and acetonitrile as a mobile phase at pH 6.6. The flow rate was 1.0 mL/min, and a diode array detector operating at 220 nm was used for UV detection. The retention times of degradants Deg1, Deg2, ibuprofen (IBU), and phenylephrine hydrochloride (PHE) were 2.0, 2.2, 3.2 and 7.0 min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness using ICH guidelines. The linearities of ibuprofen and phenylephrine hydrochloride were in the range of 10–100 μg/mL and 0.3–10 μg/mL, respectively. The % recoveries of the two drugs were found to be 100.75 ± 1.44%, 99.67% ± 1.67, and the LOD was found to be 2.75/mL and 0.09/mL for IBU, and PHE, respectively. The method was successfully applied to the estimation of ibuprofen and phenylephrine hydrochloride combination in pharmaceutical dosage form. The proposed technique was validated using ICH guidelines and its greenness was assessed according to Analytical Eco Scale metric (AES). Molecular docking was used to assess the two drugs and PHE oxidative degradants interaction with the stationary phase and to confirm the outcomes of the proposed method with regard to the order of elution of the two drugs and PHE degradation products. Eco-friendly and environmental safety were assessed through the application of one of the most applicable greenness assessment tool; Analytical Eco Scale metric (AES).

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“…The RSD% not exceeding 4% and Er% not exceeding 10% indicate good stability of the drugs under all the studied conditions. Further forced degradation studies will be conducted by the authors in a future study to investigate the stability of the combinations under different conditions as done in their previous assays [20].…”

Section: Recovery Validationmentioning

confidence: 99%

HPLC-fluorescence detection for assay of tramadol binary mixtures with ibuprofen or chlorzoxazone in tablets and plasma: Analytical Eco-Scale and GAPI tools for green assessment

Hamdy

Moneim

2021

AChrom

Self Cite

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Tramadol, a strong pain killer known for its addictive problems is either co-administrated or co-formulated with other analgesics or muscle relaxants. The power of fluorescence detection in HPLC is tested to resolve such mixtures in plasma matrix to reach the required sensitivity with simple sample treatment using just protein precipitation. The aim of this work was to develop an eco-friendly and sensitive HPLC method with fluorimetric detection for analysis of Tramadol in its two binary mixtures with Ibuprofen (mixture 1) and Chlorzoxazone (mixture 2) in two combined dosage forms and spiked plasma. Separation was done using a C18 column with mobile phase of acetonitrile and water (pH 3.5) in gradient elution and 1 mL/min flow rate. Detection was carried out with λ excitation/λ emission of 220 and 307 nm, respectively. The method was applied to detect the two binary mixtures in real plasma samples after invivo application to rats, to assure that the drugs’ metabolites do not affect the sensitivity or selectivity of the assay. Evaluation of greenness of the proposed method was done using semi-quantitative Eco‐Scale and new Green Analytical Procedure Index which showed that this method can be a greener alternative with higher sensitivity for analysis of both mixtures. The method (15 min-assay) was linear over concentrations of 0.1–10 μg/mL and 0.1–33 μg/mL in plasma. In addition, the proposed method was validated per ICH as well as FDA bioanalytical methods’ validation guidelines.

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Stability Studies of Over the Counter Quaternary Mixture Containing Phenylephrine Hydrochloride, Chlorpheniramine Maleate, Paracetamol and Caffeine Using Different Chromatographic Methods

Cited by 6 publications

References 15 publications

Accelerated stability study of the ester prodrug remdesivir: Recently FDA‐approved Covid‐19 antiviral using reversed‐phase‐HPLC with fluorimetric and diode array detection

Accelerated stability study of the ester prodrug remdesivir: Recently FDA‐approved Covid‐19 antiviral using reversed‐phase‐HPLC with fluorimetric and diode array detection

Development of an eco-friendly HPLC method for the stability indicating assay of binary mixture of ibuprofen and phenylephrine

HPLC-fluorescence detection for assay of tramadol binary mixtures with ibuprofen or chlorzoxazone in tablets and plasma: Analytical Eco-Scale and GAPI tools for green assessment

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