Aravind Raj, R (2017) Development of Validated Analytical Methods for the Simultaneous Determination of Metformin and Teneligliptin from Tablet Dosage form. Masters thesis, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore.
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Abstract
INTRODUCTION: 1.Qualitative methods: A qualitative method yields information about the identity of atomic or molecular species or the functional groups in the sample. Identification may be based on differences in colour, odour, melting point, boiling point, radioactivity or reactivity. 2.Quantitative methods:A quantitative method provides numerical information as to the relative amount of one or more of these components. It uses mass or volume changes to quantify amount. INSTRUMENTAL METHODS: The instruments used for the analysis of methods are given below: a) X – ray diffraction b) UV – Visible Spectroscopy c) Raman spectroscopy d) Refractrometry e) Polarimetry f) Potentiometry g)Polarography h) Conductometry i) Mass spectrometry AIM AND PLAN OF WORK: Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. According to WHO, around 422 million adults have diabetes and 1.5 million deaths are directly attributed to diabetes each year.16 Antidiabetic drugs can be used alone or in combination for the management of diabetes. Metformin is an oral anti-hyperglycaemic drug belonging to the class of biguanides which is used in the management of type 2 diabetes.17 Teneligliptin is a third generation dipeptidyl peptidase-4 inhibitor approved for treatment of type 2 diabetes. Combination of these drugs has been recently launched and it has been reported that teneligliptin coadministered with metformin produced significant reductions in HbA1c in patients with type 2 diabetes mellitus without increasing the risk of hypoglycemia.18 No HPTLC and HPLC methods have been reported for the simultaneous analysis of these drugs in combined dosage form. Hence, an attempt is made to develop HPTLC and HPLC methods for the simultaneous determination of metformin and teneligliptin in tablet dosage form. SUMMARY AND CONCLUSION: Literature survey reveals no RP-HPLC and HPTLC methods for the simultaneous determination of metformin and teneligliptin in pharmaceutical dosage form. An attempt was made to develop validated methods like RP-HPLC and HPTLC for the simultaneous analysis of metformin and teneligliptin in combined dosage form.HPTLC METHOD: For the determination of metformin and teneligliptin by HPTLC method different mobile phase systems were tried. It was found that a system comprising of methanol: tetrahydrofuran: ammonia (7: 3: 0.1, v/v/v) gave good separation with symmetric peaks, (Rf value of 0.29 ± 0.02 for metformin and 0.71 ± 0.02 for teneligliptin) at the selected wavelength of 258 nm. The method was validated as per ICH guidelines. Calibration curves were plotted with peak areas of standard drug versus concentration. Metformin was found to be linear in the concentration range of 6.25 to 17.5 g/band. Teneligliptin was found to be linear in the concentration range of 0.25 to 7 g/band. The LOD values for metformin and teneligliptin were found to be 0.01 and 0.1g/band, and their LOQ values were found to be 0.07 and 0.4g/band respectively. %RSD values for precision studies were found to be less than 2 which shows that the method is precise. Recovery studies were carried out at 80%, 100% and 120% levels. Good recovery values show that the method is free from interferences. This method was successfully used for the simultaneous determination of metformin and teneligliptin from pharmaceutical dosage form. Peak purity studies of the drugs (peak purity index values close to 1) showed that no impurities or degradation products eluted with drug peaks.RP-HPLC METHOD: In RP-HPLC method, optimizations of different chromatographic parameters like selection of chromatographic method, detection wavelength, selection of mobile phase, mobile phase ratio, etc., were done. A wavelength of 247 nm was selected for the study. It was found that a system comprising of 10 mM potassium dihydrogen orthophosphate: methanol (35: 65, v/v) gave good resolution and peak characteristics, (retention times of metformin = 3 minutes and teneligliptin = 4.6 minutes). The method was validated as per ICH guidelines. Calibration curves were plotted with concentration versus peak area.
| Item Type: | Thesis (Masters) |
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| Additional Information: | REG. No. 261530101 |
| Uncontrolled Keywords: | Validated Analytical Methods ; Simultaneous Determination ; Metformin ; Teneligliptin from ; Tablet Dosage form |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Apr 2018 06:27 |
| Last Modified: | 03 Apr 2018 06:27 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6817 |
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