Stability Indicating Spectrophotometric Method for the Estimation of Glimepiride in Bulk and Various Marketed Brands of Tablets (original) (raw)
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Spectrophotometric Method for the Estimation of Glimepiride in Bulk and Pharmaceutical formulations
2009
A simple, sensitive and resproducible spectrophotometric method for the analysis of glimepiride in pure form and in pharmaceutical formaulations has been developed. glimepiride is a synthetic oral hypoglycemic agent, which belongs to the class of sulfonylureas used in treatment of type- 2 diabetes mellitus. Glimepiride exhibited maximum absorbance at 226.0 nm with an apparent molar absorptivity of 2.94 x 106. Beer’s law was obeyed in the concentration range of 2-32 μg/mL. Results of the analysis were validated statistically and by recovery studies. This method is successfully employed for the determination of glimepiride in various pharmaceutical preparations.
Development and Validation of Direct Spectrophotometric Method for the Estimation of Glimepiride
Journal of Pharmaceutical Research International, 2021
Aims: To develop simple, sensitive and direct spectrophotometric methods for the estimation of widely prescribed antidiabetic hypoglycemic agent Glimepiride in pure and pharmaceutical dosage form. Place and duration of study: Research Centre of Taywade Group of Institution Koradi, Nagpur affiliated to Rashtrasant Tukadoji Maharaj Nagpur University Nagpur between June 2020 and March 2021. Methodology: Two spectrophotometric methods were developed based on ion-pair formation of drug with Cresol Red dye (Method A) and Bromophenol Blue dye (Method B) in methanol and chloroform. The possible reaction mechanism was proposed with evaluation of statistical parameters. The methods were validated for its application to determine Glimepiride in bulk as well as in pharmaceutical formulations Results: The Beer's law was found linear in the range 10 - 60 µgml-1 at 450 nm for method A and 2 - 20 µgml-1 at 578 nm for method B, respectively. The linear regression equation obtained by applying le...
International Journal of Pharmacy and Pharmaceutical Sciences, 2016
Objective: A simple, direct and accurate spectrophotometric method has been developed for the determination of glimepiride (GLM) in pure and pharmaceutical formulations by complex formation with bromocresol green (BCG). Methods: The method involves the formation of a yellow ion-pair complex between bromocresol green reagent with glimepiride (C24H34N4O5S); after reacted it with Na2CO3 to give C24H33N4H + O5NaS in chloroform at pH≤3.8. Results: The formed complex was measured at λmax 416 nm against the reagent blank prepared in the same manner. Variables were studied in order to optimize the reaction conditions. Beer's law was obeyed in the concentration range of 0.981-9.812 μg/ml in the present of 1x10-4 mol/l of (BCG) and 9.812-58.874 μg/ml in the present of 1x10-3 mol/l of (BCG) with good correlation coefficient (R 2 = 0.9992 and R 2 = 0.9997, respectively). The relative standard deviation did not exceed 3.0%. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.088 and 0.29 μg/ml, respectively. The proposed method was validated for specificity, linearity, precision and accuracy, repeatability, sensitivity (LOD and LOQ), and robustness with average recovers 98.9 to 102.4%. Conclusion: The developed method is applicable for the determination of glimepiride in pure and different dosage forms with average assay of marketed formulations 97.8 to 102.4% and the results are in good agreement with those obtained by the RP-HPLC reference method.
Glimepiride: A Review of Analytical Methods
Glimepiride is an oral anti-diabetic drug, which is mostly used in the treatment of Type 2 diabetes mellitus. It acts by stimulating insulin secretions from the beta cells of pancreas and is also known to enhance the peripheral insulin sensitivity thereby decreasing insulin resistance. This article examines published analytical methods that are reported so far for the determination of glimepiride in pharmaceutical formulations and biological samples. They include various techniques like spectrophotometry, electrochemical methods, capillary electrophoresis, high-performance liquid chromatography, micellarelectro kinetic capillary chromatography(MECC) with diode-array detection (DAD), liquid chromatography-electrospray ionization-tandem mass spectroscopy (LC-ESI-MS), liquid chromatography-mass spectroscopy (LC-MS) and thin layer chromatography (TLC).
Glimepiride is a third generation sulphonylurea antidiabetic drug. It shows low, pH dependent solubility thus is classified as class II drug according to Biopharmaceutics Classification Systems (BCS). The poor solubility of the drug may cause poor dissolution and unpredicted bioavailability. Scientists can ask for biowaivers in case of Class I compounds if they are formulated as immediate release oral dosage forms. Class II drugs are also the candidates for a waiver of bioequivalence and bioavailability studies. In the present study developed dissolution medium was easy to prepare, stable over a longer period, simple and cost-effective. In vitro dissolution test was performed using 2% SLS as the medium of dissolution in USP apparatus II (paddle) at 100 rpm, for glimepiride tablet could reliably discriminate among different products. Drug release was found above 95% within 30 min. To explain the kinetics of released drug contents, various statistical models including First-order, Zero-order Higuchi’s, Hixson-Crowell’s, and Weibull’s were used. Glimepiride was best fitted to the Weibull’s kinetics. Furthermore, goodness-offit test, the mean square error and the Akaike Information Criterion were used for selection of appropriate model; f2 test was applied for comparison of similarity between the release profile of various trial marketed brands.
A simple, selective and accurate thin layer chromatography (TLC)-densitometry method has been developed and validated for analysis of glimepiride in tablets. Glimepiride assay was performed by TLC-densitometry using silica gel 60 F 254 plates as the stationary phase and a mixture of chloroform : methanol (9 : 1) as the best mobile phase. Standard solution of glimepiride in the range of 100-500 ppm resulted in a regression equation y = 1221.03 + 17.9959x with r = 0.9973. Glimepiride detection limit was 44.10598 ppm and the limit of quantification of glimepiride was 133.6545 ppm. Accuracy was obtained percent recovery for glimepiride was 101.19 % ± 2.67 % for Metrix ® (PT Kalbe Farma) and 100.86 % ± 1,83 % for generic tablet (PT Dexa Medica). Precision intraday and interday had good repeatability as RSD ≤ 2 %. The analysis showed levels of glimepiride on a generic tablet of 104.68 % ± 0.50 % and glimepiride tablets under the trade name of 104.49 % ± 0.60 %. The levels glimepiride obtained have suitably qualified Indonesian Pharmacopoeia edition V, i.e. 90-110 %.
International Journal of Pharmacy and Pharmaceutical Sciences, 2016
Objective: A simple, direct and accurate spectrophotometric method has been developed for the determination of glimepiride (GLM) in pure and pharmaceutical formulations by complex formation with bromocresol green (BCG). Methods: The method involves the formation of a yellow ion-pair complex between bromocresol green reagent with glimepiride (C 24 H 34 N 4 O 5 S); after reacted it with Na 2 CO 3 to give C 24 H 33 N 4 H + O 5 NaS in chloroform at pH≤3.8. Results: The formed complex was measured at l max 416 nm against the reagent blank prepared in the same manner. Variables were studied in order to optimize the reaction conditions. Beer’s law was obeyed in the concentration range of 0.981-9.812 μg/ml in the present of 1x10 -4 mol/l of (BCG) and 9.812-58.874 μg/ml in the present of 1x10 -3 mol/l of (BCG) with good correlation coefficient (R 2 = 0.9992 and R 2 = 0.9997, respectively). The relative standard deviation did not exceed 3.0%. The limit of detection (LOD) and the limit of quan...
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE
The present work demonstrates a simple, rapid, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for analyzing glimepiride in pure and tablet forms. The present method was developed using a C18 column 150 × 4.6 mm, with 5 μm, and packing L1 maintained at a temperature of 30°C. The mobile phase was prepared by dissolving 0.5 gram of monobasic sodium phosphate in 500 mL of distilled water, pH of the solution adjusted to 2.1 to 2.7 with 10% phosphoric acid, and added 500 mL of acetonitrile. The mobile phase was pumped in the highperformance liquid chromatography (HPLC) system at a flow rate of 1 mL/min, and separation was carried out at 228 nm, using an ultraviolet (UV) detector. The chromatographic separation was achieved with peak retention time (RT) at about 9.30 minutes, and the method was found to be linear over a concentration range of 40 to 140 μg/mL. The specificity of the method represented no interference of the excipients ...
Bioequivalence assessment of the two brands of glimepiride tablets
Vojnosanitetski pregled, 2006
Background/Aim. Glimepiride, as an antidiabetic from the group of sulfonylurea, is administered perorally in the treatment of diabetes mellitus. The aim of this study was to compare pharmacokinetic profiles and relative bioavailabilities of the two oral formulations of glimepiride, generic and innovator tablets, after a single dose of the active drug. Methods. An oral dose of 6 mg glimepiride was given under fasting conditions to 24 healthy volunteers. A one-week washout period was applied between the two consecutive periods. The serum samples obtained before dosing, and at various time points up to 48 hours, were analyzed for glimepiride concentration using the validated highperformance liquid chromatographic method with ultraviolet detection. Pharmacokinetic parameters representing early (maximal concentration, time to reach maximal concentration) and total exposure (area under the curve from the time 0 to the infinite time) to glimepiride were obtained and further analyzed using ...
Biowaiver Study of Immediate Release Glimepiride Tablets
International Journal of Applied Pharmaceutics
Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions. Methods: The quality of the tablet products, including uniformity of weight, friability, and disintegration test, was assessed using the United State Pharmacopeia (USP) general monograph for the tablet dosage form. The content of glimepiride in the tablets was measured using UV spectrophotometer at the wavelength 229 nm. The release of Glimepiride from the tested and originator tablet products was evaluated using the dissolution profiles conducted in HCI buffer pH 1.2, and phosphate buffer pH 6.4 and 7.8 by USP dissolution apparatus II. The bioequivalence of test products was assessed using the similarity and difference factors. Results:The tested products complied to USP...