Degradation Kinetics Study of Alogliptin Benzoate in Alkaline Medium by Validated Stability-Indicating HPTLC Method.
A rapid, sensitive, and stability-indicating high-performance thin-layer chromatographic method was developed and validated to study degradation kinetics of Alogliptin benzoate (ALG) in an alkaline medium. ALG was degraded under acidic, alkaline, oxidative, and thermal stress conditions. The degraded samples were chromatographed on silica gel 60F254-TLC plates, developed using a quaternary-solvent system (chloroform-methanol-ethyl acetate-triethyl amine, 9+1+1+0.5, v/v/v/v), and scanned at 278 nm. The developed method was validated per International Conference on Harmonization guidelines using validation parameters such as specificity, linearity and range, precision, accuracy, LOD, and LOQ. The linearity range for ALG was 100-500 ng/band (correlation coefficient = 0.9997) with an average recovery of 99.47%. The LOD and LOQ for ALG were 9.8 and 32.7 ng/band, respectively. The developed method was successfully applied for the quantitative estimation of ALG in its synthetic mixture with common excipients. Degradation kinetics of ALG in an alkaline medium was studied by degrading it under three different temperatures and three different concentrations of alkali. Degradation of ALG in the alkaline medium was found to follow first-order kinetics. Contour plots have been generated to predict degradation rate constant, half-life, and shelf life of ALG in various combinations of temperature and concentration of alkali using Design Expert software.
Maliba Pharmacy College, Department of Quality Assurance, Gopal Vidyanagar, Bardoli-Mahuva Rd, Tarsadi, Surat, Gujarat 394350, India.
Kunjan Bharatkumar
KB
Bodiwala
Maliba Pharmacy College, Department of Quality Assurance, Gopal Vidyanagar, Bardoli-Mahuva Rd, Tarsadi, Surat, Gujarat 394350, India.
Shailesh
S
Shah
Maliba Pharmacy College, Department of Quality Assurance, Gopal Vidyanagar, Bardoli-Mahuva Rd, Tarsadi, Surat, Gujarat 394350, India.
Jeenal
J
Thakor
Maliba Pharmacy College, Department of Quality Assurance, Gopal Vidyanagar, Bardoli-Mahuva Rd, Tarsadi, Surat, Gujarat 394350, India.
Bhavin
B
Marolia
Maliba Pharmacy College, Department of Quality Assurance, Gopal Vidyanagar, Bardoli-Mahuva Rd, Tarsadi, Surat, Gujarat 394350, India.
Pintu
P
Prajapati
D001565:Benzoates / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000592:standards*; D004355:Drug Stability; D007700:Kinetics; D010880:Piperidines / Q000737:chemistry*; D012972:Sodium Hydroxide / Q000737:chemistry*; D014498:Uracil / Q000031:analogs & derivatives* / Q000737:chemistry
D001565:Benzoates; D010880:Piperidines; D012972:Sodium Hydroxide; D014498:Uracil; C520853:alogliptin