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Staff Researches

Asmaa Mandour

Simultaneous determination of ciprofloxacin hydrochloride and metronidazole in spiked human plasma by ultra performance liquid chromatography-tandem mass spectroscopy

Asmaa Abdelkereim Mandour Khedr

Ramzia El-bagary, Asmaa Ahmed El-Zaher, Ehab Elkady

International Pharmaceutical Federation 74 th World Congress of Pharmacy and Pharmaceutical Sciences (FIP)

2014

Ciprofloxacin HCl (CIP) and Metronidazole (MET) are antibacterial drugs used in combination for treatment of mixed aerobic/anaerobic infections. An UPLC-MS/MS method was developed for the simultaneous estimation of CIP and MET in spiked human plasma using sildenafil citrate as an internal standard (IS). Protein precipitation was used for analyte extraction. The chromatographic separation was completed within 6 min using a mobile phase of 0.1% formic acid in water and acetonitrile (70: 30, v/v), Zorbax C18, 100 x 4.6 mm, 3.5 μm analytical column, at a flow rate of 0.5 mL min-1. Multiple reaction monitoring (MRM) transitions were measured in the positive ion mode. Validation of the method showed standard curves to be linear in the range of 10-4000 ng mL-1 for CIP and 30-12000 ng mL-1 for MET with mean correlation coefficient exceeding 0.999. In human plasma, CIP and MET were stable for at least 36 days at –70 ± 5 °C, 6 hours at ambient temperature and after three freeze thaw cycles. After extraction from plasma, the samples were stable in auto sampler at 22 °C for 6 hours. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies.

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Stability Indicating HPLC Method for the Simultaneous Determination of Ciprofloxacin

Asmaa Abdelkereim Mandour Khedr

Ramzia I. El-Bagary, Asmaa A. El-Zaher, Ehab F. Elkady, Maha M. El-Hakim

International Pharmaceutical Federation 74 th World Congress of Pharmacy and Pharmaceutical Sciences (FIP)

2014

A stability indicating HPLC method for the simultaneous determination of ciprofloxacin HCl (CIP) and metronidazole (MET) in presence of ciprofloxacin acid degradation product (DEG) is presented (Method I, MI). The present study is concerned with the development and validation of an environmentally friendly method with relatively low organic composition of the mobile phase. The chromatographic separation of the two drugs was performed using Kromasil 100-5C18 (150 mm x 4.6 mm) with UV detection at 280 nm and flow rate of 1 mLmin-1. The mobile phase consisted of 0.5% aqueous phosphoric acid and acetonitrile (90:10 v/v) MI. In addition, another HPLC method (MII) for the separation of the same binary mixture using 0.5% aqueous phosphoric acid and acetonitrile (80:20 v/v) was presented. Retention times were 2.40, 3.10 & 22.94 min for MET, DEG and CIP, respectively, MI. On the other hand, the retention times were 2.03 and 4.00 min for MET and CIP, respectively MII. However, the relatively low organic composition of the mobile phase of 10% in MI was advantageous regarding green analytical procedure concept. Linearity, accuracy and precision were acceptable over the concentration range of 1-65 μgmL-1 for both drugs MI, and 1-80 μgmL-1 MII. The method is new, simple , sensitive and suitable for the routine quality control and dosage form assay of both drugs in the presence of the acid degradation product of ciprofloxacin. The method showed sufficient accuracy with a mobile phase of only 10% organic composition showing advantage and trying to approach green chromatographic conditions.

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An UHPLC (ultra high performance liquid chromatography) Method for the Simultaneous Determination of Norfloxacin, Metronidazole and Tinidazole using Monolithic Column-Stability Indicating Application

Asmaa Abdelkereim Mandour Khedr

Ramzia El-Bagary, Asmaa El-Zaher, Ehab Elkady

ICPPC 2016: International Conference on Pharmacognosy and Pharmaceutical Chemistry

2016

Abstract— Background: An UHPLC (ultra high performance liquid chromatography) method for the simultaneous determination of norfloxacin (NOR), metronidazole (MET) and tinidazole (TNZ) using monolithic column is presented. Purpose: The method is considered an enviromentally friendly method with relatively low organic composition of the mobile phase. Methods: The chromatographic separation was performed using Phenomenex® Onyex Monolithic C18 (50mmx 20mm) column. An elution program of mobile phase consisted of 0.5% aqueous phosphoric acid : methanol (85:15, v/v). Where elution of all drugs was completed within 3.5 min with 1µL injection volume. The UHPLC method was applied for the stability indication of NOR in presence of its acid degradation product ND. Results: Retention times were 0.69, 1.19 and 3.23 min for MET, TNZ and NOR, respectively. While ND retention time was 1.06 min. Linearity, accuracy and precision were acceptable over the concentration range of 5-50µg mL-1for all drugs. Conclusions: The method is simple, sensitive and suitable for the routine quality control and dosage form assay of the three drugs and can also be used for the stability indication of NOR in presence of its acid degradation product.

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Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in spiked Human Plasma by Ultra Performance Liquid Chromatography- Tandem Mass Spectroscopy

Asmaa Abdelkereim Mandour Khedr

Ramzia El-Bagary, Asmaa Ahmed El-Zaher, Ehab Elkady

Journal of Applied Pharmaceutical Science

2016

Ciprofloxacin HCl (CIP) and Metronidazole (MET) are antibacterial drugs used in combination for treatment of mixed aerobic/anaerobic infections. An UPLC-MS/MS method was developed for the simultaneous estimation of CIP and MET in spiked human plasma using sildenafil citrate as an internal standard (IS). Protein precipitation was used for analyte extraction. The chromatographic separation was completed within 6 min using a mobile phase of 0.1% formic acid in water and acetonitrile (70: 30, v/v), Zorbax C18, 100 x 4.6 mm, 3.5 μm analytical column, at a flow rate of 0.5 mL min-1. Multiple reaction monitoring (MRM) transitions were measured in the positive ion mode. Validation of the method showed standard curves to be linear in the range of 10-4000 ng mL-1 for CIP and 30-12000 ng mL-1 for MET with mean correlation coefficient exceeding 0.999. In human plasma, CIP and MET were stable for at least 36 days at –70 ± 5 °C, 6 hours at ambient temperature and after three freeze thaw cycles. After extraction from plasma, the samples were stable in auto sampler at 22 °C for 6 hours. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies.

Download PDF
Stability Indicating HPLC Method for the Simultaneous Determination of Ciprofloxacin

Asmaa Abdelkereim Mandour Khedr

Ramzia I. El-Bagary, Asmaa A. El-Zaher, Ehab F. Elkady, Maha M. El-Hakim

Asian Journal of Biochemical and Pharmaceutical Research

2015

A stability indicating HPLC method for the simultaneous determination of ciprofloxacin HCl (CIP) and metronidazole (MET) in presence of ciprofloxacin acid degradation product (DEG) is presented (Method I, MI). The present study is concerned with the development and validation of an environmentally friendly method with relatively low organic composition of the mobile phase. The chromatographic separation of the two drugs was performed using Kromasil 100-5C18 (150 mm x 4.6 mm) with UV detection at 280 nm and flow rate of 1 mLmin-1. The mobile phase consisted of 0.5% aqueous phosphoric acid and acetonitrile (90:10 v/v) MI. In addition, another HPLC method (MII) for the separation of the same binary mixture using 0.5% aqueous phosphoric acid and acetonitrile (80:20 v/v) was presented. Retention times were 2.40, 3.10 & 22.94 min for MET, DEG and CIP, respectively, MI. On the other hand, the retention times were 2.03 and 4.00 min for MET and CIP, respectively MII. However, the relatively low organic composition of the mobile phase of 10% in MI was advantageous regarding green analytical procedure concept. Linearity, accuracy and precision were acceptable over the concentration range of 1-65 μgmL-1 for both drugs MI, and 1-80 μgmL-1 MII. The method is new, simple , sensitive and suitable for the routine quality control and dosage form assay of both drugs in the presence of the acid degradation product of ciprofloxacin. The method showed sufficient accuracy with a mobile phase of only 10% organic composition showing advantage and trying to approach green chromatographic conditions.

Download PDF
Stability Indicating HPLC Method for the Simultaneous Determination of Ciprofloxacin

Asmaa Abdelkereim Mandour Khedr

Ramzia I. El-Bagary, Asmaa A. El-Zaher, Ehab F. Elkady, Maha M. El-Hakim

3nd FUE International Conference of Pharmaceutical Sciences (3rd FUE ICPS)

2015

A stability indicating HPLC method for the simultaneous determination of ciprofloxacin HCl (CIP) and metronidazole (MET) in presence of ciprofloxacin acid degradation product (DEG) is presented (Method I, MI). The present study is concerned with the development and validation of an environmentally friendly method with relatively low organic composition of the mobile phase. The chromatographic separation of the two drugs was performed using Kromasil 100-5C18 (150 mm x 4.6 mm) with UV detection at 280 nm and flow rate of 1 mLmin-1. The mobile phase consisted of 0.5% aqueous phosphoric acid and acetonitrile (90:10 v/v) MI. In addition, another HPLC method (MII) for the separation of the same binary mixture using 0.5% aqueous phosphoric acid and acetonitrile (80:20 v/v) was presented. Retention times were 2.40, 3.10 & 22.94 min for MET, DEG and CIP, respectively, MI. On the other hand, the retention times were 2.03 and 4.00 min for MET and CIP, respectively MII. However, the relatively low organic composition of the mobile phase of 10% in MI was advantageous regarding green analytical procedure concept. Linearity, accuracy and precision were acceptable over the concentration range of 1-65 μgmL-1 for both drugs MI, and 1-80 μgmL-1 MII. The method is new, simple , sensitive and suitable for the routine quality control and dosage form assay of both drugs in the presence of the acid degradation product of ciprofloxacin. The method showed sufficient accuracy with a mobile phase of only 10% organic composition showing advantage and trying to approach green chromatographic conditions.

Download PDF
Simultaneous determination of ciprofloxacin hydrochloride and metronidazole in spiked human plasma by ultra performance liquid chromatography-tandem mass spectroscopy

Asmaa Abdelkereim Mandour Khedr

Ramzia El-bagary, Asmaa Ahmed El-Zaher, Ehab Elkady

3nd FUE International Conference of Pharmaceutical Sciences (3rd FUE ICPS)

2015

Ciprofloxacin HCl (CIP) and Metronidazole (MET) are antibacterial drugs used in combination for treatment of mixed aerobic/anaerobic infections. An UPLC-MS/MS method was developed for the simultaneous estimation of CIP and MET in spiked human plasma using sildenafil citrate as an internal standard (IS). Protein precipitation was used for analyte extraction. The chromatographic separation was completed within 6 min using a mobile phase of 0.1% formic acid in water and acetonitrile (70: 30, v/v), Zorbax C18, 100 x 4.6 mm, 3.5 μm analytical column, at a flow rate of 0.5 mL min-1. Multiple reaction monitoring (MRM) transitions were measured in the positive ion mode. Validation of the method showed standard curves to be linear in the range of 10-4000 ng mL-1 for CIP and 30-12000 ng mL-1 for MET with mean correlation coefficient exceeding 0.999. In human plasma, CIP and MET were stable for at least 36 days at –70 ± 5 °C, 6 hours at ambient temperature and after three freeze thaw cycles. After extraction from plasma, the samples were stable in auto sampler at 22 °C for 6 hours. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies.

Download PDF

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