BackgroundLevofloxacin hemihydrate (LEV) and ambroxol HCl (AMB) are available for the treatment of upper and lower respiratory tract infections. A survey of the literature reveals that two reversed phase HPLC methods were e reported for the simultaneous determination of LEV and AMB in pharmaceutical preparations. However the reported methods suffers from the low sensitivity, no application of the method in the combined tablets and no application to biological fluids. Also the toxic effects of the used solvents which are harmful to human beings. For this reason, our target was to develop a simple sensitive, less hazardous micellar HPLC method for the simultaneous determination of LEV and AMB in their combined dosage forms and plasma.ResultsThe method showed good linearity over the ranges of 1–44 μg/mL and 1–20 μg/mL with limits of detection 0.26 and 0.07 μg/mL and limits of quantification 0.80 and 0.20 μg/mL for LEV and AMB, respectively. The method was further extended to the determination of LEV in spiked human plasma with mean percentage recoveries of 100.10% ± 1.14 as well as determination of LEV in real human plasma without prior extraction. Statistical evaluation of the data was performed according to ICH Guidelines.ConclusionThe suggested method was successfully applied for the simultaneous analysis of the studied drugs in their co-formulated tablets and human plasma. The mean percentage recoveries in combined tablets were 100.20 ± 1.64 and 100.72 ± 1.11 for LEV and AMB, respectively and 100.10 ± 1.14 for LEV in spiked human plasma. Statistical comparison of the results with those of the comparison method revealed good agreement and proved that there were no significant difference in the accuracy and precision between the two methods respectively.
A simple and rapid liquid chromatographic method was developed and validated for the determination of triclabendazole with high accuracy and precision within 6 min. Good chromatographic separation was achieved using a CLC Shim-pack C8 (250 × 4.6 mm, 5 µm particle size) using the mobile phase containing a mixture of 0.02 m phosphate buffer and methanol with a ratio of (20 : 80 v/v) at pH 4.0 was pumped at a flow rate of 1.2 mL/min with fluorescence detection for the first time at 338 nm after excitation at 298 nm. Losartan potassium was used as an internal standard. The method showed good linearity in the ranges of 0.05-2.0 µg/mL with limits of detection and quantification of 14.1 and 42.6 ng/mL, respectively. The suggested method was successfully applied for the analysis of triclabendazole in tablets. The high sensitivity of the method enabled the determination of the studied drug in spiked human plasma with mean percentage of recoveries of 99.79 ± 5.09. Statistical evaluation of the data was performed according to ICH Guidelines.
A green, simple, quick and economical method is implemented for the first time for the simultaneous estimation of cetirizine (CTZ) and azelastine (AZE) as co-administered eye drops. The method relies on synchronous spectrofluorimetry with ∆λ = 60 nm. Cetirizine can be estimated at 231 nm and AZE can be measured at 294 nm, each at the other’s zero crossing point. All factors affecting the method were studied and properly optimized. Good correlation was obtained in the range of 0.1–2 µg mL−1 for both drugs. The limits of detection were 0.014 and 0.010 µg mL−1 and limits of quantitation were 0.043 and 0.029 µg mL−1 for CTZ and AZE, respectively. Moreover, ICH guidelines were carried out to validate the adopted method. The method was suitable for the analysis of CTZ and AZE in synthetic mixtures, eye drops and aqueous humor. The mean percentage of recoveries of CTZ and AZE in spiked aqueous humor were 99.83 and 99.37, respectively. Furthermore, Green Analytical Procedure Index (GAPI) and analytical Eco-scale approaches were used to evaluate the greenness of the suggested method.
A simple and rapid liquid chromatographic method was developed and validated for the first time for the simultaneous determination of betamethasone valerate (BETA) and clioquinol (CLIO) in creams. Good chromatographic separation was achieved within less than 4 minutes using a Shim-Pack (150 mm  4.6 mm i.d) CLC-cyanopropyl-bonded stationary phase. The mobile phase consisted of a mixture of methanol and 0.02 M phosphate buffer at a ratio of (55 : 45) v/v at pH 4.0 pumped at a flow rate of 1 mL min À1 with UV detection at 240 nm for BETA and 280 nm for CLIO. The method showed good linearity over the concentration ranges of 2-30 and 15-150 mg mL À1 with limits of detection of 0.46 and 2.01 mg mL À1 and limits of quantification of 1.40 and 6.10 mg mL À1 for BETA and CLIO, respectively.The suggested method was successfully applied in the simultaneous analysis of the studied drugs in their commercial creams with mean percentage recoveries of 94.99% AE 0.81 and 95.34% AE 0.60 for BETA and CLIO, respectively. Statistical evaluation of the data was performed according to ICH guidelines.
A new, simple and selective HPLC method was implemented for the simultaneous estimation of tafluprost (TFL) and timolol (TIM) in their new anti-glaucoma combination in the challengeable ratio of 3 and 1000 for TFL and TIM, respectively. Separation was achieved using a BDS Hypersil phenyl column and a mobile phase made up of acetonitrile: 0.015 M phosphate buffer (50:50 v/v, pH 3.5) delivered at 1 mL min−1 and the separation was completed in less than 6 min. UV detection was time programmed at 220 nm for the first 4.5 min and later at 254 nm. Mebeverine (MEB) was used as an internal standard (I.S.). The linearity was observed in the ranges of 0.6–45 and 50–2000 µg mL−1 with limits of detection (LOD) of 0.18, 16.48 µg mL−1 and limits of quantification (LOQ) of 0.55, 49.94 µg mL−1 for TFL and TIM, respectively. The method satisfied International Council for Harmonization (ICH) validation guidelines. The study was extended to the estimation of the studied drugs in their co-formulated eye drops as well as in their single dosage forms with acceptable percentage recoveries. Moreover, Green Analytical Procedure Index (GAPI) and analytical Eco-scale were investigated to confirm the greenness of the proposed HPLC method.
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