JOURNAL 1893


Journal of Chemical Metrology
VOLUME & ISSUE
Year: 2021 Issue: 1 January-June
PAGES
p.65 - 75
STATISTICS
Viewed 285 times.
AUTHORS
  • Mehul Patel
  • Divya Patel
  • Umang Shah
  • Hetaben M. Kachhiya
PDF OF ARTICLE

GRAPHICAL ABSTRACT


ABSTRACT


Simple, rapid, sensitive, robust, and validated high-performance thin-layer chromatography was developed for the simultaneous determination of anti-diabetic drugs Teneligliptin hydrobromide (TH) and Metformin hydrochloride (MH) in bulk and pharmaceutical formulation. HPTLC system equipped Camag Linomat V, TLC Scanner IV, Twin Trough chamber, Dual-wavelength UV Cabinet, and win CATS software V1.4.7 were used during the study. Separation of analytes were achieved using a pre-coated silica gel G60 F254 aluminum Sheets 10×10 cm2, with the thickness of 0.2 mm as stationary phase and a mobile phase comprising of Methanol: Ammonium sulfate (0.5 %w/v): Triethylamine (9: 2.7: 0.5 v/v/v). The detection wavelength was set at 237 nm. The Rf value of the TH and MH was 0.63 and 0.19, respectively. The method was validated using a dynamic linear range of  4-28 ng/band and 100-700 ng/band for TH and MH, respectively. The developed method was validated as per the ICHQ2 (R1) guideline. The statistical analysis proved that the method is accurate with 98.80–99.38 % w/v and 99.66–99.96 % w/v for TH and MH, respectively, and precise with less than 2 % RSD. The Plackett-Burman design was applied to check the robustness of the developed method. Finally, the method is termed as linear, precise, accurate, and robust. It can be implemented successfully for the routine analysis of pharmaceutical dosage forms comprising TH and MH and is appropriate for regulatory submission under regulatory flexibility.

KEYWORDS
  • : Teneligliptin hydrobromide
  • metformin hydrochloride
  • high-performance thin-layer chromatography
  • ICH guidelines
  • simultaneous estimation
  • quality by design

SUPPORTING INFORMATION


Supporting Information
Download File A6-55-JCM-2011-1893-SI.pdf (457.49 KB)