METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY ON GLIMEPIRIDE IN TABLET DOSAGE FORM BY RP-UFLC
Journal Title: International Journal of Pharmaceutical Sciences and Research (IJPSR) - Year 2019, Vol 10, Issue 9
Abstract
The study aimed to develop a specific, exact, selective, precise and accurate Reversed-Phase Stability Indicating Ultra-fast Liquid Chromatography (RP-UFLC) strategy is created and validated for the determination of glimepiride in the tablet dosage form. The method showed an adequate separation for glimepiride from their degradation products. The optimum separation was achieved by using 250 mm × 4.6 mm C18 column (5 μm) with a mixture of potassium dihydrogen orthophosphate adjusted to pH 4.6 using (orthophosphoric acid) and acetonitrile in the ratio of 75:25 at a flow rate of 1 ml/min. The detection was carried out at 236 nm, and the retention time was found to be 5.9 min. Linearity was observed (correlation coefficient r2 0.9989). % R.S.D was found to be less than 2%. Accuracy of the method found to be in the range of 98.0 to 102.00 (% w/w). The above method was validated concerning system suitability, linearity, precision, the limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery) and robustness according to ICH guidelines. The linearity of the above methods was found to be 2-10 µg/ml for glimepiride and force degradation were carried out. Hence these methods can be used for routine analysis in quality control laboratories.
Authors and Affiliations
R. Maruthi et al.
Keywords
Related Articles
- EP ID EP627599
- DOI 10.13040/IJPSR.0975-8232.10(9).4345-53
- Views 101
- Downloads 0
IN-SILICO MOLECULAR SCREENING OF NATURAL PLANT PRODUCTS FOR THE IDENTIFICATION OF NOVEL POTENTIAL CHEMOTHERAPEUTIC AGENTS AGAINST BREAST CANCER
In-silico computational approaches help in ascertaining drug targets via bioinformatics tools. HER2 is the most valuable therapeutic target for breast cancer therapy. The overexpression of HER2 protein plays a very criti...
FORMULATION AND EVALUATION OF ANTIHYPERTENSIVE BILAYER TABLET
The present research work was carried out to Formulate and evaluation of bilayer tablet dosage form for the treatment of Hypertension. The objective of this study to compare the specific characteristics of Olmesartan Mid...
COMPARISON OF THE TOXICOLOGICAL EFFECT OF LEAD-BASED HERBO-MINERAL PREPARATIONS AND THEIR CORRESPONDING METAL NANO-PARTICLE ON ENZYMATIC ACTIVITY AND GROWTH OF BAKER’S YEAST
Metallic toxicity associated with Ayurvedic formulations like herbomineral preparation (Bhasma), especially because of heavy metals such as lead, has always been a matter of debate in the scientific community. Instead of...
AN OVERVIEW ON ANALYTICAL METHODS FOR DAPAGLIFLOZIN – AN ANTIDIABETIC DRUG
Dapagliflozin (DAPA) is a drug of gliflozin class. It is a white crystalline solid. Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin bl...
A REVIEW ON FUNCTIONALITY ASSESSMENT OF MULTIFUNCTIONAL EXCIPIENTS
Multifunctional excipients are class of excipients that includes pre-processed and co-processed excipients that provide added functionalities to the formulation. Functionality is a desirable property of the material that...