Bioanalytical method for the estimation of co-administered esomeprazole, leflunomide and ibuprofen in human plasma and in pharmaceutical dosage forms using micellar liquid chromatography

Objective: The objective of the study was to develop and validate a novel, specific, precise, and simple reversed-phase high-performance liquid chromatography method for the estimation of guaifenesin present in methocarbamol API and its pharmaceutical dosage forms. Methods: The baseline separation for methocarbamol and guaifenesin was achieved by utilizing a Inertsil ODS C18 (250 mm × 4.6 mm) 5 μm column particle size and an isocratic elution method. The mobile phase contains a mixture of water and acetonitrile in the ratio of 70:30 v/v, respectively. The flow rate of the mobile phase was 1.0 mL/min with a column temperature of 25°C and detection wavelength at 272 nm. The method was validated for a limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, and reproducibility with the help of the exhibit and simulated samples. Results: The LOD for guaifenesin was 0.62 μg/mL. The LOQ for guaifenesin was 1.87 μg/mL. The correlation coefficient obtained for impurity was >0.99. The recovery was obtained for impurity was 106.56% at 50%, 95.20% at 100%, and 100.45% at 150%. In tablet analysis, we can found 0.26% (<0.5%). Conclusion: The developed method was validated as per the ICH guidelines with respect to specificity, precision, linearity, accuracy, LOD and quantification, ruggedness, robustness, and solution stability.

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Enhanced selectivity approach for fast analysis of enalaprilat, lisinopril and benazepril in pharmaceutical dosage forms and spiked human plasma by ion chromatography

African Journal of Pharmacy and Pharmacology ◽

10.5897/ajpp11.759 ◽

2013 ◽

Vol 7 (35) ◽

pp. 2504-2513

Author(s):

Fawzi Elsebaei

Keyword(s):

Human Plasma ◽

Ion Chromatography ◽

Dosage Forms ◽

Fast Analysis ◽

Pharmaceutical Dosage Forms ◽

Spiked Human Plasma ◽

Enhanced Selectivity

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Core–shell particles and monolithic columns; tools for simultaneous LC analysis of avanafil, sildenafil, apomorphine, trazodone, yohimbine, tramadol and dapoxetine in pharmaceutical dosage forms, counterfeit products and human plasma

RSC Advances ◽

10.1039/c9ra08717f ◽

2020 ◽

Vol 10 (3) ◽

pp. 1379-1387 ◽

Cited By ~ 5

Author(s):

Adel Ehab Ibrahim ◽

Hisham Hashem ◽

Magda Elhenawee ◽

Hanaa Saleh

Keyword(s):

Human Plasma ◽

Dosage Forms ◽

Sexual Disorders ◽

Monolithic Columns ◽

Core Shell ◽

Pharmaceutical Dosage Forms ◽

Shell Particles ◽

Counterfeit Products

By 2025, it's estimated that 322 million males worldwide will suffer from sexual disorders. This study provides two simple green tools for analysis of some male sexual enhancers using HPLC on core–shell particles and monolithic RP-columns.

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Simultaneous Determination of Floctafenine and its Hydrolytic Degradation Product Floctafenic Acid Using Micellar Liquid Chromatography with Applications to Tablets and Human Plasma

Journal of AOAC International ◽

10.5740/jaoacint.11-255 ◽

2013 ◽

Vol 96 (6) ◽

pp. 1315-1324 ◽

Cited By ~ 5

Author(s):

Mohamed I Walash ◽

Fathalla Belal ◽

Nahed El-Enany ◽

Manal Eid ◽

Rania N El-Shaheny

Keyword(s):

Liquid Chromatography ◽

Human Plasma ◽

Degradation Product ◽

Mobile Phase ◽

Sodium Dodecyl ◽

Hydrolytic Degradation ◽

Direct Determination ◽

Micellar Liquid Chromatography ◽

Main Metabolite

Abstract A stability-indicating micellar liquid chromatography (MLC) method was developed and validated for the assay of floctafenine (FLF) in the presence of its degradation product and main metabolite, floctafenic acid (FLA). The analysis was carried out on a CLC Shim-Pack octyl silane (C8) column (150 × 4.6 mm id, 5 μm particle size) using a micellar mobile phase consisting of 0.15 M sodium dodecyl sulfate, 10% n-propanol, and 0.3% triethylamine in 0.02 M orthophosphoric acid (pH = 3). The mobile phase was pumped at a flow rate of 1.0 mL/min with UV detection at 360 nm. The method showed good linearity for FLF and FLA over the concentration ranges of 0.5–25.0 and 0.4–10.0 μg/mL, with LODs of 0.16 and 0.12 μg/mL, respectively. The developed method was successfully applied to the determination of FLF in commercial dispersible tablets, with mean recovery of 98.87 ± 1.37%. Also, the proposed method was specific for the analysis of FLF in presence of the co-formulated drug thiocolchicoside in laboratory-prepared tablets, with mean recovery of 100.50 ± 1.07%. Statistical comparison of the results obtained by the proposed MLC method with those obtained by a comparison method showed good agreement. Moreover, the method was extended to study the degradation behavior of FLF under different International Conference on Harmonization recommended conditions such as alkaline, acidic, oxidative, thermal, and photolytic. The method was further applied for direct determination of FLA as the main metabolite of FLF in human plasma without prior extraction steps, with mean recovery of 110.50 ± 6.5%.

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