HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TWO ANTIDIABETIC DRUGS IN BULK AND TABLET DOSAGE FORM Authors: Pancholi P , DODIYA T, PATEL V* AND PANCHAL P
ABSTRACT
Metformin HCl (MET) and Remogliflozin Etabonate (REM) is a new drug combination used
for treating diabetes mellitus. It is necessary to estimate the drugs in the combined dosage
form. For the simultaneous quantification of metformin HCl and remogliflozin etabonate,
high-performance thin layer chromatography (HPTLC) was devised in the current
investigation. For separation Merck pre-coated silica gel aluminium plate 60 F254 was used as
stationary phase and Acetone: methanol: chloroform: Formic acid (3: 1: 5: 1) as mobile
phase. A camag TLC scanner was used to densitometrically scan plates at 224 nm to quantify
the medication. The method has been tested for linearity, precision, accuracy, and robustness
by ICH criteria. The response was found linear over the concentration range of 100-600ng/band with a regression value of 0.999 for both the drugs. Metformin's LOD and LOQ were
reported to be 5.34 and 17.81 ng/band, but remogliflozin's LOD and LOQ were reported to be
11.03 and 33.45 ng/band. This method can be used for its intended purpose because they are
highly sensitive, accurate and precise.
Keywords: Metformin HCl, Remogliflozin etabonate, Validation, Densitometric, High-
Performance Thin Layer chromatography Publication date: 01/08/2023 https://ijbpas.com/pdf/2023/August/MS_IJBPAS_2023_7364.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.8.7364