DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC ASSAY METHOD FOR ESTIMATION OF SITAGLIPTIN PHOSPHATEAbstract
An Accurate, sensitive, precise and stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the estimation of SITA-P. The method was developed using TLC aluminium plates precoated with silica gel 60F254 as the stationary phase using ethyl acetate: methanol: formic acid (8.5:1:0.5 v/v/v) as mobile phase. Densitometric analysis of SITA-P was carried out in the absorbance mode at 265 nm. The retention factor for SITA-P was found to be 0.50 ± 0.04. Linearity was found to be 500 – 2500 ng/band for SITA-P. The method was found to be accurate, precise, and robust according to acceptance criteria. The limit of detection (LOD) and (LOQ) was found to be 124.36 ng/band and 376.87 ng/band for SITA-P respectively. The drug was subjected to stress condition. The method was validated for different parameters as per the International Conference for Harmonization guidelines (ICH). This HPTLC method can be used for the determination for the stability indicating assay methods for bulk drug and its formulations.
A. S. Tapkir*, S. M. Biradar and P. D. Chaudhari
Department of Pharmaceutical Chemistry, Progressive Education Society’s, Modern College of Pharmacy, Pune, Maharashtra, India.
22 February, 2017
12 April, 2017
17 April, 2017
01 October, 2017