Investigations of Some Hypoglycemic Drugs by New Analytical Techniques
Mariam Mamdouh Fawzy Tadros;
Abstract
PART (I): Introduction and literature review
Introduction to Diabetes Mellitus was discussed with mentioning all categories of oral hypoglycemic drugs. Literature review was conducted for the studied drugs including alogliptin benzoate, pioglitazone hydrochloride, linagliptin and empagliflozin.
PART (II): Chromatographic Methods PART II, SECTION (A):
Enhanced LC-MS/MS analysis of alogliptin benzoate and pioglitazone hydrochloride in human plasma, application to a pharmacokinetic study
A new fast LC-MS/MS method was developed for determination of alogliptin benzoate and pioglitazone hydrochloride in human plasma. Linearity ranges of 10-400 ng mL-1 for alogliptin benzoate and 25-2000 ng mL-1 for pioglitazone hydrochloride, were found to be suitable for their bioanalysis covering the Cmin and Cmax values of the drugs. Direct precipitation technique was used for simultaneous extraction of the drugs successfully from human plasma samples. The validated method was applied to a pharmacokinetic study on human volunteers. Chromatographic separation was achieved on a BEH C18 column (50 mm
× 2.1 mm, 1.7 µm) with 0.1% aqueous formic acid: acetonitrile (40:60,
v/v) at a flow rate of 0.3 mL min-1. Monitoring the transition pairs of m/z
340.18 to 116.08 for alogliptin benzoate and m/z 356.99 to 133.92 for pioglitazone hydrochloride, using triple quadrupole mass spectrometer with multiple reaction monitoring, was achieved in the positive mode. The validated method is accurate and suitable for further clinical applications and possible bioequivalence studies.
PART II, SECTION (B):
LC-MS/MS analysis of linagliptin and empagliflozin in bulk and in pharmaceutical formulation
A new LC-MS/MS method was developed for determination of linagliptin and empagliflozin in pharmaceutical pure forms and dosage forms. Regression parameters, LOD, LOQ, accuracy and precision were investigated. Linearity was found to be acceptable over the concentration ranges of 25 - 800 ng mL-1 and 50 - 1600 ng mL-1 for linagliptin and empagliflozin, respectively. A mixture of 0.1 %
Introduction to Diabetes Mellitus was discussed with mentioning all categories of oral hypoglycemic drugs. Literature review was conducted for the studied drugs including alogliptin benzoate, pioglitazone hydrochloride, linagliptin and empagliflozin.
PART (II): Chromatographic Methods PART II, SECTION (A):
Enhanced LC-MS/MS analysis of alogliptin benzoate and pioglitazone hydrochloride in human plasma, application to a pharmacokinetic study
A new fast LC-MS/MS method was developed for determination of alogliptin benzoate and pioglitazone hydrochloride in human plasma. Linearity ranges of 10-400 ng mL-1 for alogliptin benzoate and 25-2000 ng mL-1 for pioglitazone hydrochloride, were found to be suitable for their bioanalysis covering the Cmin and Cmax values of the drugs. Direct precipitation technique was used for simultaneous extraction of the drugs successfully from human plasma samples. The validated method was applied to a pharmacokinetic study on human volunteers. Chromatographic separation was achieved on a BEH C18 column (50 mm
× 2.1 mm, 1.7 µm) with 0.1% aqueous formic acid: acetonitrile (40:60,
v/v) at a flow rate of 0.3 mL min-1. Monitoring the transition pairs of m/z
340.18 to 116.08 for alogliptin benzoate and m/z 356.99 to 133.92 for pioglitazone hydrochloride, using triple quadrupole mass spectrometer with multiple reaction monitoring, was achieved in the positive mode. The validated method is accurate and suitable for further clinical applications and possible bioequivalence studies.
PART II, SECTION (B):
LC-MS/MS analysis of linagliptin and empagliflozin in bulk and in pharmaceutical formulation
A new LC-MS/MS method was developed for determination of linagliptin and empagliflozin in pharmaceutical pure forms and dosage forms. Regression parameters, LOD, LOQ, accuracy and precision were investigated. Linearity was found to be acceptable over the concentration ranges of 25 - 800 ng mL-1 and 50 - 1600 ng mL-1 for linagliptin and empagliflozin, respectively. A mixture of 0.1 %
Other data
| Title | Investigations of Some Hypoglycemic Drugs by New Analytical Techniques | Authors | Mariam Mamdouh Fawzy Tadros | Issue Date | 2018 |
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