Abstract
Alpha glucoside inhibitors used to treat type-2 diabetes mellitus (DM) are likely to be safe and effective. These agents are most effective for postprandial hyperglycemia. Miglitol is a type of drug used to treat type-2 DM. A simple, selective, linear, precise and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for a related substance of miglitol and its identification, and characterization was done by different mass spectrometry techniques. The gradient method at a flow rate of 1.0 mL/min was employed on a prevail carbohydrate ES column (250 × 4.6 mm, 5 μm particle size) at a temperature of 35 °C. Mobile phase A consisted of 10 mM dipotassium hydrogen orthophosphate adjusted to pH 8.0 using concentrated phosphoric acid and mobile phase B consisted of acetonitrile. The ultraviolet detection wavelength was 210 nm and 20 μL of the sample were injected. The retention time for miglitol was about 24.0 min. Forced degradation of the miglitol sample was conducted in accordance with the International Conference on Harmonisation (ICH) guidelines. Acidic, basic, neutral, and oxidative hydrolysis, thermal stress, and photolytic degradation were used to assess the stability-indicating the power of the method. Substantial degradation was observed during oxidative hydrolysis. No degradation was observed under the other stress conditions. The method was optimized using samples generated by forced degradation and sample solutions spiked with impurities and epimers. Good resolution of the analyte peak from peaks, corresponding to process-related impurities, epimers and degradation products, was achieved and the method was validated as per the ICH guidelines. The method can successfully be applied for routine analysis of miglitol.
Highlights
Diabetes mellitus (DM) is known as diabetes, a lifelong, progressive disease, which is a chronic metabolic disorder with steadily increasing prevalence all over the world
No cure has been found yet for the disease; treatment modalities including lifestyle modification, treatment of obesity, oral hypoglycemic agents and insulin sensitizers that reduce insulin resistance are still recommended as first line treatment [3]
The fragmentation was studied with high collision energy 50 eV, in which many smaller fragmentation peaks were observed making the interpretation of the fragmentation pattern more complex
Summary
Diabetes mellitus (DM) is known as diabetes, a lifelong, progressive disease, which is a chronic metabolic disorder with steadily increasing prevalence all over the world. No cure has been found yet for the disease; treatment modalities including lifestyle modification, treatment of obesity, oral hypoglycemic agents and insulin sensitizers that reduce insulin resistance are still recommended as first line treatment [3]. Miglitol ((2R,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol) is an oral anti-diabetic drug and an inhibitor of the intestinal α-glucosidase. The inhibition of the glucosidase activity in the intestinal brush border blocks the breakdown of starch and disaccharides to absorbable monosaccharides, which results in a decrease in the intestinal absorption of starch, disaccharides and dextrin, leading to carbohydrate malabsorption and blunting of the postprandial rise in blood glucose. The current indications include the management of glycemic control in type 2 diabetes, used in combination with diet and exercise, with or without other oral hypoglycemic agents or insulin. Miglitol causes malabsorption and gastrointestinal side effects are common including flatulence, diarrhea and abdominal boating
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