Study on the Development and Validation of Direct Spectrophotometric Method for the Estimation of Glimepiride | Chapter 1 | Current Aspects in Pharmaceutical Research and Development Vol. 4

 

Developing simple, sensitive, and direct spectrophotometric methods for estimating the frequently prescribed antidiabetic hypoglycemia drug Glimepiride in pure and pharmaceutical dosage form.

For the creation of procedures, the spectrophotometric methodology was used. For developed approaches, optimization of reaction parameters and spectral features is required. Propose a reaction mechanism for the methods that have been created. Implementation of developed technologies for drug measurement in formulations. Validation of the devised approach in accordance with ICH recommendations.

Methodology: In methanol and chloroform, two spectrophotometric techniques based on drug ion-pair production with Cresol Red dye (Method A) and Bromophenol Blue dye (Method B) were established. With the use of statistical characteristics, a plausible reaction mechanism was developed. The procedures were approved for use in determining Glimepiride in both bulk and pharmaceutical formulations.

The Beer's law was found to be linear in the 10-60 gml-1 range at 450 nm for technique A and 2-20 gml-1 range at 578 nm for method B, respectively. For glimepiride, the linear regression equation was found to be Absorbance = 0.0136 x Concentration in gml-1 + 0.028; R2 = 0.9965 for method A and Absorbance = 0.0428 x Concentration in gml-1 + 0.0722; R2 = 0.9949 for method B using least square regression analysis. For methods A and B, the Sandell's sensitivity was determined to be 0.0696 and 0.0177, respectively. For both approaches, the apparent molar absorptivity was calculated to be 6.6724 x103 and 2.0999 x104 l mol-1 cm-1, respectively.

Conclusion: Two direct spectrophotometric techniques for determining Glimepiride have been successfully developed and validated according to ICH criteria for sensitivity, accuracy, precision, repeatability, and robustness. The suggested methods are suited for estimating Glimepiride in pure and dose form on a regular basis. The established approaches can be used in analytical laboratories as a tool for drug quality control.

Author(S) Details

Dilip M. Chafle
Research Centre of Taywade College, Koradi, Dist. Nagpur (441111), India.

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Determining the Efficacy and Safety of Teneligliptin and Metformin Versus Glimepiride and Metformin in Patients of Type-2 Diabetes Mellitus Uncontrolled with Monotherapy | Chapter 6 | Technological Innovation in Pharmaceutical Research Vol. 10

 Type 2 diabetes mellitus is one of the most common non-communicable diseases, with both short- and long-term effects.

Material and Methods: The study included 60 patients, divided into two groups of 30 patients each. Teneligliptin 10 mg once a day and metformin 500 mg twice a day after meals were administered to Group 1 participants for 12 weeks. Glimepiride 1 mg once a day and metformin 500 mg twice a day after meals were administered to Group 2 patients for 12 weeks. Following the signed consent, the patient's medical history, clinical examination, and biochemical tests such as FBG, PPBG, HbA1c, and lipid profile were performed. FBG and PPBG were repeated every week for a total of 12 weeks. HbA1c and lipid profiles were measured at the start and end of the trial.

The change in FBG was greater in group 1 than in group 2. When comparing the drop in PPBG in patients in groups 1 and 2 there was a highly significant difference in group 1. HbA1c, total cholesterol, triglyceride levels, HDL, and LDL levels all changed more in group 1 than in group 2.

Conclusion: When compared to Glimepiride and metformin, teneligliptin and metformin resulted in a larger improvement in glycaemic and lipid profiles. Teneligliptin is therefore more effective than glimepiride.

Author (S) Details

Nitika Hans
Department of Pharmacology, Government Medical College, Amritsar, Punjab, India.

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The Improvement in Cardiovascular Risk Markers with Glimepiride in Pre-diabetic non-obese Subjects: Similar to Obese Cohort Treated with Metformin | Chapter 13 | Highlights on Medicine and Medical Research Vol. 5

 Background: Over a 5- to 9-year period (mean, 7.20.2), we found that glimepiride was more effective than metformin in delaying the progression from pre-diabetes to type 2 diabetes in non-obese subjects. Metformin was the first-line treatment for newly diagnosed diabetics who were overweight. Furthermore, neither group experienced any deaths or adverse cardiovascular conditions, which could be due to beneficial improvements in lipids and cardiovascular surrogate markers. The impact of interventions on lipids and cardiovascular surrogate markers, on the other hand, was not documented.

Prior to intervention, cardiovascular risk factors such as lipid fractions, such as serum Total cholesterol (TC), Triglyceride (TG), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), and other markers, such as homocysteine (HomC), highly sensitive C-Reactive Protein (CRP), Fibrinogen (FIBR), and Plasminogen Activator Inhibitor1 (PAI1).

Subjects and Methods: The sample included 18 non-obese subjects, 10 men and 8 women between the ages of 27 and 78, and 20 obese subjects, 10 men and 10 women between the ages of 32 and 81, who had pre-diabetes (fasting plasma glucose of 100 to 125 mg/dl and/or HbA1c of 5.7 to 6.4 percent). The research lasted 5 to 9 years (mean: 7.20.2). Glimepiride was given to non-obese subjects, while metformin was given to obese subjects. At each visit during the study, subjects were counselled on lifestyle intervention (appropriate diet and exercise).Individual lipids and CV markers were compared at the start of the study, six months later, and at the end of the study for each group, as well as between groups for baseline and end-of-study levels.

Results: In the glimepiride group, significant improvements in all parameters occurred after treatment (Post Rx) at 6 months and were sustained until the end of the study. HbA1C ( percent ): 6.2 0.2, 5.5 0.1*, 5.7 0.1*; TC (mg/dl): 212 15, 174 13*, 178 14*; TG (mg/dl): 202 32, 162 28*, 178 14*; LD HDLC was not affected in any way. Obese people who were given metformin experienced similar improvements. There were no major differences between the two groups at the start, 6 months, or end of the research.

Conclusion: Glimepiride is equally efficient in enhancing lipid profiles and cardiovascular surrogate markers in nonobese subjects with Pre diabetes as metformin is in obese subjects, explaining similar cardiovascular results in both classes.

Author (s) Details

Reshma Esmail
Mount Saint Mary College, Los Angeles, California, USA.

Udaya Manohar Kabadi
University of Iowa, Iowa City, Iowa, USA and Des Moines University, Des Moines, Iowa, USA.

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