A comparative study of first-derivative spectrophotometry and column high-performance liquid chromatography applied to the determination of repaglinide in tablets and for dissolution testing.
A fast and reliable method for the determination of repaglinide is highly desirable to support formulation screening and quality control. A first-derivative UV spectroscopic method was developed for the determination of repaglinide in tablet dosage form and for dissolution testing. First-derivative UV absorbance was measured at 253 nm. The developed method was validated for linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ) in comparison to the U.S. Pharmacopeia (USP) column high-performance liquid chromatographic (HPLC) method. The first-derivative UV spectrophotometric method showed excellent linearity [correlation coefficient (r) = 0.9999] in the concentration range of 1-35 microg/mL and precision (relative standard deviation < 1.5%). The LOD and LOQ were 0.23 and 0.72 microg/mL, respectively, and good recoveries were achieved (98-101.8%). Statistical comparison of results of the first-derivative UV spectrophotometric and the USP HPLC methods using the t-test showed that there was no significant difference between the 2 methods. Additionally, the method was successfully used for the dissolution test of repaglinide and was found to be reliable, simple, fast, and inexpensive.
AlKhalidi
Bashar A
BA
University of Jordan, Faculty of Pharmacy, Queen Rania St, Amman, 11942, Jordan. b.khalidi@ju.edu.jo
Shtaiwi
Majed
M
AlKhatib
Hatim S
HS
Mohammad
Mohammad
M
Bustanji
Yasser
Y
D002219:Carbamates / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D010880:Piperidines / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D013607:Tablets
D002219:Carbamates; D010880:Piperidines; D013607:Tablets; C072379:repaglinide