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Papers by Ola El-Shoubashy
Sustainable Chemistry and Pharmacy, Apr 1, 2022
Newly established green TLC-densitometric and RP-HPLC methods were developed and validated for si... more Newly established green TLC-densitometric and RP-HPLC methods were developed and validated for simultaneous determination of quetiapine (QUT) (an antipsychotic drug) and the co-administrated drug, paroxetine (PAR) (an antidepressant drug). Both drugs are widely prescribed for treatment of bipolar depression. The proposed TLC-densitometric method was based on separation of the studied components and the internal standard (vincamine (VINC)) using a developed system of ethyl acetate: ethanol: ammonia solution 33% (8: 2:0.05, by volume) on TLC silica gel 60 F 254 plates and scanning at 240 nm. Linear relationships were obtained over a concentration range of 150-3000 ng/band for both using 1000 ng/mL of vincamine (VINC) as an internal standard. On the other hand, the proposed RP-HPLC method depended on separation of the studied components and the internal standard (vincamine) using a mixture of methanol: 0.05 M KH 2 PO 4 (pH 4.3) (70:30, v/v) on XTerra® HPLC RP C18 column (4.6 mm × 250 mm, 5 µm) at a flow rate of 1 mL/min, and UV detection at 240 nm. Linearity was achieved on the concentration range of 150-5000 ng/mL for both using 1000 ng/mL of VINC as an internal standard. The greenness profile of the developed methods was assessed and compared with reported HPLC method using the analytical Eco-Scale as an assessment tool. The proposed methods were found to be greener than the reported method. Furthermore, the developed methods were validated following FDA guidelines and all parameters met the acceptance criteria. In addition, they were successfully used to study the pharmacokinetic parameters of both QUT and PAR after their co-administration in rats and results showed that both drugs affected the pharmacokinetic parameters of each other when administrated together. The developed methods can be used for further monitoring of the studied drugs in patients.
Microchemical Journal, Jul 1, 2023
Sustainable Chemistry and Pharmacy, 2022
JPC – Journal of Planar Chromatography – Modern TLC, 2020
Qternmet XR® (FDA approval, May 2019) is a multitarget anti-diabetic drug combination composed of... more Qternmet XR® (FDA approval, May 2019) is a multitarget anti-diabetic drug combination composed of metformin (MET), saxagliptin (SAX) and dapagliflozin (DAP). To our present knowledge, no analytical reports were found in the scientific databases for the simultaneous quantification of MET, SAX and DAP in their ternary combined tablets, moreover, no articles have attempted the simultaneous estimation of the cited drugs in any matrix using high-performance liquid chromatography with diode-array detection (HPLC–DAD) or high-performance thin-layer chromatography (HPTLC) technique. The current work represents a comparative study on two developed and validated chromatographic methods for the simultaneous determination of the ternary mixture (MET, SAX and DAP) in pure form and in combined tablet dosage form. The first method is reversed-phase HPLC using Agilent C18 column (4.6 × 250 mm, 5 μm p.s.) with a mobile phase consisting of acetonitrile and acidic aqueous phase pH 3 with a photodiode array detection at 230 nm. The second method is HPTLC in which drug solutions were applied to Merck HPTLC silica gel plates developed with a mixture of chloroform:methanol:water:acetic acid (7.4:2.6:0.5:0.01, v/v ) and scanned at 224 nm. Both methods were fully validated following the ICH guidelines in terms of linearity, accuracy, precision, selectivity and robustness. Graphical abstract Representative HPLC ( a ) and HPTLC ( b ) chromatograms for a ternary mixture of metformin (MET), saxagliptin (SAX) and dapagliflozin (DAP)
Sustainable Chemistry and Pharmacy, Apr 1, 2022
Newly established green TLC-densitometric and RP-HPLC methods were developed and validated for si... more Newly established green TLC-densitometric and RP-HPLC methods were developed and validated for simultaneous determination of quetiapine (QUT) (an antipsychotic drug) and the co-administrated drug, paroxetine (PAR) (an antidepressant drug). Both drugs are widely prescribed for treatment of bipolar depression. The proposed TLC-densitometric method was based on separation of the studied components and the internal standard (vincamine (VINC)) using a developed system of ethyl acetate: ethanol: ammonia solution 33% (8: 2:0.05, by volume) on TLC silica gel 60 F 254 plates and scanning at 240 nm. Linear relationships were obtained over a concentration range of 150-3000 ng/band for both using 1000 ng/mL of vincamine (VINC) as an internal standard. On the other hand, the proposed RP-HPLC method depended on separation of the studied components and the internal standard (vincamine) using a mixture of methanol: 0.05 M KH 2 PO 4 (pH 4.3) (70:30, v/v) on XTerra® HPLC RP C18 column (4.6 mm × 250 mm, 5 µm) at a flow rate of 1 mL/min, and UV detection at 240 nm. Linearity was achieved on the concentration range of 150-5000 ng/mL for both using 1000 ng/mL of VINC as an internal standard. The greenness profile of the developed methods was assessed and compared with reported HPLC method using the analytical Eco-Scale as an assessment tool. The proposed methods were found to be greener than the reported method. Furthermore, the developed methods were validated following FDA guidelines and all parameters met the acceptance criteria. In addition, they were successfully used to study the pharmacokinetic parameters of both QUT and PAR after their co-administration in rats and results showed that both drugs affected the pharmacokinetic parameters of each other when administrated together. The developed methods can be used for further monitoring of the studied drugs in patients.
Microchemical Journal, Jul 1, 2023
Sustainable Chemistry and Pharmacy, 2022
JPC – Journal of Planar Chromatography – Modern TLC, 2020
Qternmet XR® (FDA approval, May 2019) is a multitarget anti-diabetic drug combination composed of... more Qternmet XR® (FDA approval, May 2019) is a multitarget anti-diabetic drug combination composed of metformin (MET), saxagliptin (SAX) and dapagliflozin (DAP). To our present knowledge, no analytical reports were found in the scientific databases for the simultaneous quantification of MET, SAX and DAP in their ternary combined tablets, moreover, no articles have attempted the simultaneous estimation of the cited drugs in any matrix using high-performance liquid chromatography with diode-array detection (HPLC–DAD) or high-performance thin-layer chromatography (HPTLC) technique. The current work represents a comparative study on two developed and validated chromatographic methods for the simultaneous determination of the ternary mixture (MET, SAX and DAP) in pure form and in combined tablet dosage form. The first method is reversed-phase HPLC using Agilent C18 column (4.6 × 250 mm, 5 μm p.s.) with a mobile phase consisting of acetonitrile and acidic aqueous phase pH 3 with a photodiode array detection at 230 nm. The second method is HPTLC in which drug solutions were applied to Merck HPTLC silica gel plates developed with a mixture of chloroform:methanol:water:acetic acid (7.4:2.6:0.5:0.01, v/v ) and scanned at 224 nm. Both methods were fully validated following the ICH guidelines in terms of linearity, accuracy, precision, selectivity and robustness. Graphical abstract Representative HPLC ( a ) and HPTLC ( b ) chromatograms for a ternary mixture of metformin (MET), saxagliptin (SAX) and dapagliflozin (DAP)