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Nadia F Youssef - One of the best experts on this subject based on the ideXlab platform.
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stability testing followed by manipulating mean centering ratio and derivative ratio spectrophotometric methods for the determination of Gliquidone in presence of its induced degradation products
Analytical Chemistry Letters, 2018Co-Authors: Ali M Yehia, Mohamed R Elghobashy, Aya H Helmy, Nadia F YoussefAbstract:AbstractStability testing on Gliquidone was conducted under different conditions followed by adoption of two smart and selective spectrophotometric methods namely; mean centering of ratio spectra and derivative ratio for the determination of Gliquidone in presence of alkaline degradation products. Degradation products have been elucidated by LC/MS and IR spectroscopy. The spectrum of alkaline degradation products (10 μg/ml) was chosen as a divisor to resolve the overlapped spectra of Gliquidone and its degradation products. Mean centering of ratio spectra method depends on using Matlab software and measuring the mean centered values at 260 nm. Derivative ratio method is based on the measurements of analytical signal at 253 nm. Instrumental parameters and divisor concentration were carefully studied. The adopted methods have been validated as per International Conference on Harmonization guidelines. Linearity was obeyed in the range 1-18 μg/ml and detection limit was found to be 0.180, 0.324 μg/ml for mean...
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application of normal fluorescence and stability indicating derivative synchronous fluorescence spectroscopy for the determination of Gliquidone in presence of its fluorescent alkaline degradation product
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 2018Co-Authors: Mohamed R Elghobashy, Ali M Yehia, Aya H Helmy, Nadia F YoussefAbstract:Abstract Simple, smart and sensitive normal fluorescence and stability-indicating derivative synchronous spectrofluorimetric methods have been developed and validated for the determination of Gliquidone in the drug substance and drug product. Normal spectrofluorimetric method of Gliquidone was established in methanol at λ excitation 225 nm and λ emission 400 nm in concentration range 0.2–3 μg/ml with LOD equal 0.028. The fluorescence quantum yield of Gliquidone was calculated using quinine sulfate as a reference and found to be 0.542. Stability-indicating first and third derivative synchronous fluorescence spectroscopy were successfully utilized to overcome the overlapped spectra in normal fluorescence of Gliquidone and its alkaline degradation product. Derivative synchronous methods are based on using the synchronous fluorescence of Gliquidone and its degradation product in methanol at Δ λ50 nm. Peak amplitude in the first derivative of synchronous fluorescence spectra was measured at 309 nm where degradation product showed zero-crossing without interference. The peak amplitudes in the third derivative of synchronous fluorescence spectra, peak to trough were measured at 316,329 nm where degradation product showed zero-crossing. The different experimental parameters affecting the normal and synchronous fluorescence intensity of Gliquidone were studied and optimized. Moreover, the cited methods have been validated as per ICH guidelines. The peak amplitude-concentration plots of the derivative synchronous fluorescence were linear over the concentration range 0.05–2 μg/ml for Gliquidone. Limits of detection were 0.020 and 0.022 in first and third derivative synchronous spectra, respectively. The adopted methods were successfully applied to commercial tablets and the results demonstrated that the derivative synchronous fluorescence spectroscopy is a powerful stability-indicating method, suitable for routine use with a short analysis time. Statistical comparison between the results obtained by normal fluorescence and derivative synchronous methods and the official one using student's t-test and F-ratio showed no significant difference regarding accuracy and precision.
Ahmed M. Samy - One of the best experts on this subject based on the ideXlab platform.
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Optimization, in-vitro Release and in-vivo Evaluation of Gliquidone Nanoparticles
AAPS PharmSciTech, 2019Co-Authors: Mohamed S. Mohamed, Wael A. Abdelhafez, Gamal Zayed, Ahmed M. SamyAbstract:The present work embarks upon increasing the dissolution rate and the bioavailability of model anti-diabetic drug, Gliquidone, a sulfonylurea class drug used for treating diabetes mellitus type 2. The Gliquidone nanoparticles were prepared by using anti-solvent precipitation technique in which, Gliquidone solution in acetone was added at a controlled rate to an aqueous solution containing polyvinylpyrrolidone K25 (PVP K25) as stabilizer. The effect of drug concentration (X1), polymer concentration (X2) and solvent to anti-solvent ratio (X3) on particle size and dissolution was studied using Box-Behnken design. The results revealed that by decreasing the drug concentration and by increasing the stabilizer concentration and solvent/anti-solvent ratio, reduction in the size of the particles was observed. The mentioned parameters were optimised and particle of size about 175 nm was achieved. The relative dissolution rate of prepared Gliquidone nanoparticles in phosphate buffer pH 7.4 was ~ 4.7 times faster than original drug at t = 45 min. Further, the Gliquidone nanoparticles were characterized by scanning electron microscope (SEM), Fourier transform-infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and X-ray powder diffraction (XRD). The particles revealed to be oval in shape with stabilizer molecules on surface and exhibited decreased crystalline nature when compared to free Gliquidone. Finally, the in vivo studies using Gliquidone nanoparticles revealed ~ 2.5-fold increase in Cmax when taken orally in the form of hard gelatin capsules in comparison to free Gliquidone. Thus, overall investigation suggests that the developed strategy of Gliquidone nanoparticles possess a keen potential for exhibiting anti-diabetic effect.
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in vitro and in vivo characterization of fast dissolving tablets containing Gliquidone pluronic solid dispersion
Drug Development and Industrial Pharmacy, 2019Co-Authors: Mohamed S. Mohamed, Wael A. Abdelhafez, Gamal M Zayed, Ahmed M. SamyAbstract:AbstractThe main objective of this study is to increase the dissolution rate of Gliquidone using its solid dispersions with pluronic F-68 by solvent evaporation method. The solid dispersion of the ...
Najma Sultana - One of the best experts on this subject based on the ideXlab platform.
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method development and validation of amlodipine Gliquidone and pioglitazone application in the analysis of human serum
Analytical Chemistry Letters, 2014Co-Authors: Agha Zeeshan Mirza, Saeed M Arayne, Najma SultanaAbstract:AbstractA sensitive LC method has been developed for the simultaneous determination of co-administered drugs amlodipine, Gliquidone and pioglitazone in bulk drug, pharmaceutical formulations, and human serums. The assay involved an isocratic elution of analytes on a Purospher® STAR RP-18 end capped (5 μm, 25 x 0.46 cm) column at ambient temperature with a mobile phase consisting of methanol: water: acetonitrile (80:10:10 v/v/v) at a flow rate of 0.7 mLmin-1 at 230 nm. The pH was adjusted to 3.50 with phosphoric acid and glibenclamide was used as an internal standard. The linearity of the method was found to be 5-50 μgmL–1 for all the drugs with correlation coefficients were 0.9991, 0.9992 and 0.9963; the limit of detection was found to be 0.34, 0.06 and 0.33 μgmL–1 for amlodipine, Gliquidone and pioglitazone, respectively. All the validated parameters were in the acceptable range. The recovery rates of drugs were 98.2-101.53 %, 100.40-101.60 % and 98.25-101.20 % in human serum for amlodipine, Gliquidone a...
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RP-LC simultaneous quantitation of co-administered drugs for (non-insulin dependent) diabetic mellitus induced dyslipidemia in active pharmaceutical ingredient, pharmaceutical formulations and human serum with UV-detector.
Clinica Chimica Acta, 2013Co-Authors: Muhammad Saeed Arayne, Najma Sultana, Arman TabassumAbstract:Abstract Background Rapid, efficient and accurate RP-HPLC-UV method for the simultaneous determination and quality control of active pharmaceutical ingredient (API), pharmaceutical formulations and human serum containing drugs as rosuvastatin together with metformin, glimepiride and Gliquidone has been proposed. Methods The chromatographic system comprised mobile phase of methanol:water 90:10 v/v; pH adjusted to 3.0 with o-phosphoric acid, at 1 ml/min through Prepacked Purospher Star C18 (5 μm, 25 × 0.46 cm) column with UV detection at isosbestic point 231 nm. Results The method showed good linearity in the range 0.25–25 μg/ml for metformin and 0.5–50 μg/ml for rosuvastatin, glimepiride and Gliquidone with correlation co-efficient ≥ 0.998; (precision %RSD The sensitivity of method increased when drugs were analyzed after programming the detector at their individual λmax where their LODs shifted down to 5, 3, 10 and 9 ng/ml from 10, 17, 15 and 14 ng/ml when calculated at their isosbestic point respectively at least concentration 0.125 μg/ml for metformin and 0.25 μg/ml for rosuvastatin, glimepiride and Gliquidone with correlation co-efficient ≥ 0.998 in each case. Conclusions The proposed drugs can be analyzed by this method for routine analysis and clinical studies with sensitivity at nanoscale with small sample volume.
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rp lc method for the simultaneous determination of Gliquidone pioglitazone hydrochloride and atorvastatin in formulations and human serum
Journal of AOAC International, 2013Co-Authors: Agha Zeeshan Mirza, Saeed M Arayne, Najma SultanaAbstract:: The objective of this research was to develop and validate a rapid, economical, and sensitive HPLC method for quantitative determination of Gliquidone, pioglitazone hydrochloride, and atorvastatin in tablets and serum. Due to drug combination of these formulations, there has been a need for a reliable quantitative method to determine these drugs in commercial samples and human serum. The chromatographic separation was carried out at ambient temperature with a mobile phase consisting of methanol-water (90 + 10, v/v), with pH adjusted to 3.50 with phosphoric acid. The pump was operated at a flow rate of 1 mL/min, and all analytes were detected at 235 nm. The method was linear over the concentration range of 5-50 microg/mL for all the drugs. The LOD of Gliquidone, pioglitazone hydrochloride, and atorvastatin was 0.30, 1.30, and 0.57 microg/mL and LOQ was 0.98, 4.28, and 1.90 microg/mL, respectively. The proposed method was successfully applied to the determination of these drugs in commercial tablets and human serum. The established method was validated with respect to specificity, linearity, precision, accuracy, and ruggedness.
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simultaneous determination of Gliquidone pioglitazone hydrochloride and verapamil in formulation and human serum by rp hplc
Journal of Chromatographic Science, 2011Co-Authors: Saeed M Arayne, Najma Sultana, Agha Zeeshan MirzaAbstract:: In the present study, a reverse-phase high performance liquid chromatography method was developed, validated and applied for the simultaneous determination of Gliquidone, pioglitazone hydrochloride and verapamil in tablets and human serum. Chromatographic separation was achieved on a C18 column (5 μm, 25 × 0.46 cm) with a mobile phase consisting of methanol-water-acetonitrile (80:10:10 v/v/v) with a flow rate of 0.7 mL/min and pH adjusted to 3.50 with phosphoric acid at 230 nm. Glibenclamide was used as internal standard. The experimentally derived limit of detection and limit of quantitation were determined to be 0.24, 0.93, 0.40, and 0.80, 3.11, 1.36 μg/mL for Gliquidone, pioglitazone, and verapamil, respectively. There were no interfering peaks due to the excipients present in the pharmaceutical tablets. Thus, the proposed method is simple and suitable for the simultaneous analysis of active ingredients in dosage forms and human serum.
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Drug interaction studies of Gliquidone with fexofenadine, cetirizine, and levocetirizine
Medicinal Chemistry Research, 2010Co-Authors: M. Saeed Arayne, Najma Sultana, Hina Shamshad, Agha Zeeshan MirzaAbstract:Controlling blood sugar levels is crucial for diabetic patients and is managed through administration of drugs such as Gliquidone. Coadministration of antidiabetic drugs with H_1-receptor antagonists is common but is also a source of concern due to potential coadministered drug interaction, especially in patients prone to allergic disorders. In this work, we describe in vitro drug interactions of Gliquidone with commonly coadministered H_1-receptor antagonists (fexofenadine hydrochloride, cetirizine dihydrochloride, and levocetirizine dihydrochloride). These studies were performed at 37°C in different pH environments simulating human body compartments using UV spectrophotometry and high performance liquid chromatography (HPLC). It was observed that the percentage availability values of Gliquidone and H_1-receptor antagonists were not affected in the presence of each other. No significant difference between Gliquidone and H_1-receptor antagonists and no remarkable changes in availability values were observed when these interactions were studied using UV–visible and HPLC techniques. This study thus supports the safe coadministration of Gliquidone and H_1-receptor blockers as an effective diabetic health management regimen.
Agha Zeeshan Mirza - One of the best experts on this subject based on the ideXlab platform.
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method development and validation of amlodipine Gliquidone and pioglitazone application in the analysis of human serum
Analytical Chemistry Letters, 2014Co-Authors: Agha Zeeshan Mirza, Saeed M Arayne, Najma SultanaAbstract:AbstractA sensitive LC method has been developed for the simultaneous determination of co-administered drugs amlodipine, Gliquidone and pioglitazone in bulk drug, pharmaceutical formulations, and human serums. The assay involved an isocratic elution of analytes on a Purospher® STAR RP-18 end capped (5 μm, 25 x 0.46 cm) column at ambient temperature with a mobile phase consisting of methanol: water: acetonitrile (80:10:10 v/v/v) at a flow rate of 0.7 mLmin-1 at 230 nm. The pH was adjusted to 3.50 with phosphoric acid and glibenclamide was used as an internal standard. The linearity of the method was found to be 5-50 μgmL–1 for all the drugs with correlation coefficients were 0.9991, 0.9992 and 0.9963; the limit of detection was found to be 0.34, 0.06 and 0.33 μgmL–1 for amlodipine, Gliquidone and pioglitazone, respectively. All the validated parameters were in the acceptable range. The recovery rates of drugs were 98.2-101.53 %, 100.40-101.60 % and 98.25-101.20 % in human serum for amlodipine, Gliquidone a...
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rp lc method for the simultaneous determination of Gliquidone pioglitazone hydrochloride and atorvastatin in formulations and human serum
Journal of AOAC International, 2013Co-Authors: Agha Zeeshan Mirza, Saeed M Arayne, Najma SultanaAbstract:: The objective of this research was to develop and validate a rapid, economical, and sensitive HPLC method for quantitative determination of Gliquidone, pioglitazone hydrochloride, and atorvastatin in tablets and serum. Due to drug combination of these formulations, there has been a need for a reliable quantitative method to determine these drugs in commercial samples and human serum. The chromatographic separation was carried out at ambient temperature with a mobile phase consisting of methanol-water (90 + 10, v/v), with pH adjusted to 3.50 with phosphoric acid. The pump was operated at a flow rate of 1 mL/min, and all analytes were detected at 235 nm. The method was linear over the concentration range of 5-50 microg/mL for all the drugs. The LOD of Gliquidone, pioglitazone hydrochloride, and atorvastatin was 0.30, 1.30, and 0.57 microg/mL and LOQ was 0.98, 4.28, and 1.90 microg/mL, respectively. The proposed method was successfully applied to the determination of these drugs in commercial tablets and human serum. The established method was validated with respect to specificity, linearity, precision, accuracy, and ruggedness.
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simultaneous determination of Gliquidone pioglitazone hydrochloride and verapamil in formulation and human serum by rp hplc
Journal of Chromatographic Science, 2011Co-Authors: Saeed M Arayne, Najma Sultana, Agha Zeeshan MirzaAbstract:: In the present study, a reverse-phase high performance liquid chromatography method was developed, validated and applied for the simultaneous determination of Gliquidone, pioglitazone hydrochloride and verapamil in tablets and human serum. Chromatographic separation was achieved on a C18 column (5 μm, 25 × 0.46 cm) with a mobile phase consisting of methanol-water-acetonitrile (80:10:10 v/v/v) with a flow rate of 0.7 mL/min and pH adjusted to 3.50 with phosphoric acid at 230 nm. Glibenclamide was used as internal standard. The experimentally derived limit of detection and limit of quantitation were determined to be 0.24, 0.93, 0.40, and 0.80, 3.11, 1.36 μg/mL for Gliquidone, pioglitazone, and verapamil, respectively. There were no interfering peaks due to the excipients present in the pharmaceutical tablets. Thus, the proposed method is simple and suitable for the simultaneous analysis of active ingredients in dosage forms and human serum.
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Drug interaction studies of Gliquidone with fexofenadine, cetirizine, and levocetirizine
Medicinal Chemistry Research, 2010Co-Authors: M. Saeed Arayne, Najma Sultana, Hina Shamshad, Agha Zeeshan MirzaAbstract:Controlling blood sugar levels is crucial for diabetic patients and is managed through administration of drugs such as Gliquidone. Coadministration of antidiabetic drugs with H_1-receptor antagonists is common but is also a source of concern due to potential coadministered drug interaction, especially in patients prone to allergic disorders. In this work, we describe in vitro drug interactions of Gliquidone with commonly coadministered H_1-receptor antagonists (fexofenadine hydrochloride, cetirizine dihydrochloride, and levocetirizine dihydrochloride). These studies were performed at 37°C in different pH environments simulating human body compartments using UV spectrophotometry and high performance liquid chromatography (HPLC). It was observed that the percentage availability values of Gliquidone and H_1-receptor antagonists were not affected in the presence of each other. No significant difference between Gliquidone and H_1-receptor antagonists and no remarkable changes in availability values were observed when these interactions were studied using UV–visible and HPLC techniques. This study thus supports the safe coadministration of Gliquidone and H_1-receptor blockers as an effective diabetic health management regimen.
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high performance liquid chromatographic analysis of pioglitazone Gliquidone rosuvastatin and simvastatin in formulations and human serum
Chinese Journal of Chemistry, 2010Co-Authors: Saeed M Arayne, Najma Sultana, Agha Zeeshan Mirza, Hina ShamshadAbstract:Co-administration of HMG-CoA reductase with antidiabetic drugs is most common since antidiabetic drugs are mostly prescribed for long term therapy. In the present paper, we describe the simultaneous determination of antidiabetic (pioglitazone hydrochloride and Gliquidone) in presence of statins (rosvastatin and simvastatin) in formulations and in human serum using RP-HPLC technique. The serum samples were subjected to protein precipitation with acetonitrile prior to an HPLC analysis. At a flow rate of 1 mL·min−1 isocratic elution was employed, using mobile phase consisting of methanol/water (90:10, V:V), pH 3.50 with phosphoric acid and absorbance was recorded at 235 nm. The assay was reproducible, linear (concentration range of 5–50 μg·mL−1) and accurate. The LOD and LOQ values were 1.32, 0.28, 0.05 and 0.57 μg·mL−1 and 4.39, 0.93, 0.16 and 1.90 μg·mL−1 for pioglitazone hydrochloride, Gliquidone, rosvastatin and simvastatin, respectively. There were no interfering peaks due to the excipients present in the pharmaceutical tablet and serum. Thus, the proposed method is simple and suitable for the analysis of active ingredient in tablet form and human serum.
Mohamed S. Mohamed - One of the best experts on this subject based on the ideXlab platform.
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Optimization, in-vitro Release and in-vivo Evaluation of Gliquidone Nanoparticles
AAPS PharmSciTech, 2019Co-Authors: Mohamed S. Mohamed, Wael A. Abdelhafez, Gamal Zayed, Ahmed M. SamyAbstract:The present work embarks upon increasing the dissolution rate and the bioavailability of model anti-diabetic drug, Gliquidone, a sulfonylurea class drug used for treating diabetes mellitus type 2. The Gliquidone nanoparticles were prepared by using anti-solvent precipitation technique in which, Gliquidone solution in acetone was added at a controlled rate to an aqueous solution containing polyvinylpyrrolidone K25 (PVP K25) as stabilizer. The effect of drug concentration (X1), polymer concentration (X2) and solvent to anti-solvent ratio (X3) on particle size and dissolution was studied using Box-Behnken design. The results revealed that by decreasing the drug concentration and by increasing the stabilizer concentration and solvent/anti-solvent ratio, reduction in the size of the particles was observed. The mentioned parameters were optimised and particle of size about 175 nm was achieved. The relative dissolution rate of prepared Gliquidone nanoparticles in phosphate buffer pH 7.4 was ~ 4.7 times faster than original drug at t = 45 min. Further, the Gliquidone nanoparticles were characterized by scanning electron microscope (SEM), Fourier transform-infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and X-ray powder diffraction (XRD). The particles revealed to be oval in shape with stabilizer molecules on surface and exhibited decreased crystalline nature when compared to free Gliquidone. Finally, the in vivo studies using Gliquidone nanoparticles revealed ~ 2.5-fold increase in Cmax when taken orally in the form of hard gelatin capsules in comparison to free Gliquidone. Thus, overall investigation suggests that the developed strategy of Gliquidone nanoparticles possess a keen potential for exhibiting anti-diabetic effect.
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in vitro and in vivo characterization of fast dissolving tablets containing Gliquidone pluronic solid dispersion
Drug Development and Industrial Pharmacy, 2019Co-Authors: Mohamed S. Mohamed, Wael A. Abdelhafez, Gamal M Zayed, Ahmed M. SamyAbstract:AbstractThe main objective of this study is to increase the dissolution rate of Gliquidone using its solid dispersions with pluronic F-68 by solvent evaporation method. The solid dispersion of the ...