Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Simultaneous determination of Glimepiride and Metformin hydrochloride impurities in sustained release pharmaceutical drug product by HPLC

Author(s): Shraddha Pawar, Gangadhar Meshram, Rajendra Jadhav and Yatish Bansal

A gradient method is developed for the quantitative simultaneous determination of impurities of glimepiride and metformin hydrochloride in the combined –pharmaceutical dosage form. The method is based on high- performance liquid chromatography (HPLC) on a reverse phase column of Waters Symmetry -C8,5μ 4.6 x 250mm thermo stated at 50o C, using a mobile phase of Pentane sulfonic acid sodium salt buffer pH 3.5 and acetonitrile and evaluated for its ability to simultaneously establish the level of known impurities of glimepiride and metformin Hydrochloride active as well as unknown impurities in glimepiride and metformin hydrochloride tablets. The method shows good resolution between glimepiride sulfonamide (GS), glimepiride urethane (GU), glimepiride 3- isomer (GI), metformin related compound A (MA), glimeiride (G),metformin hydrochloride (M) , unknown impurities and formulation excipients of tablets. A gradient program with UV detection at 230nm is used to quantitate all components. The developed method is validated in term of specificity, linearity and range for GS,GU,GI, MA , M and G , accuracy using spiked levels of impurities (80% -120% of the specified limit ) , precision and ruggedness. Limit of quantitation is found to be 1.50 μg mL-1 for M , 0.10 μg mL-1 for G , 0.30 μg mL-1 for MA , 0.24μg mL-1 for GS ,0.10 μg mL-1 for GU and 0.22 μg mL-1 for GI. The proposed method is successfully applied to the pharmaceutical dosage form for the determination and quantitation of known and unknown impurities in M and G tablets without any interference from the excipients.


FIND ARTICLES
SCImago Journal & Country Rank
 
kız uzun zamandır masaj salonunda çalışıyor çok sulanan erkek oluyor ama porno izle bir türlü hiç birine vermiyor Ama sonunda genç paraya sıkışıyor ve bir porno resimleri sikiş için çok para teklif eden genç adama sonunda kabul ediyor ve evlerine giren amatör pornolar maskeli hırsız genç kadının odasındaki çekmecelerde para ararken kadının seksi iç sikiş çamaşırlarına denk geliyor Onları koklayarak yarağı taş gibi oluyor daha sonra genç porno fotoğrafları kadın odaya bir den bire girince hırsızı görüyor ve bağırmaya başlıyor Hırsız hızlıca porno hikayeleri kızın ağzını elleri ile kapatarak tam kızın kalçalarını kucağına alarak sevişiyor
ankara escort
mobile bitcoin casino
Casumo no deposit bonus bitcoin nedir?