International Journal of Pharmaceutical Chemistry and Analysis

  • Year: 2017
  • Volume: 4
  • Issue: 3

Method development and validation of Teneligliptin in pharmaceutical dosage form by UV spectrophotometric methods

1Research Scholar, Faculty of Pharmacy, PAHER University, Udaipur, Rajasthan

2Professor, BN Institute of Pharmaceutical Sciences, Udaipur, Rajasthan

Abstract

Teneligliptin was estimated in tablet form by ultraviolet-spectrophotometric methods followed by distilled water as solvent. Here three methods were used for quantitative estimation of teneligliptin in tablet dosage form. Quantitative estimation of pure drug solution was done at λmax of 244 nm for method I. For measurement of response in method II peak minima of 266.4 nm was selected. Wavelength range of 238.6–247.8 nm was selected for calculating area in area under the curve method. Validation of the methods was performed according to guidelines of International Conference on Harmonisation. The % assay of the formulation by the three methods was in the range of 100.17–100.74. Graph was linear in the range of 5–70 μg/mL for zero order and AUC techniques, while 5–80 μg/mL for first order derivative technique. Good correlation between response and concentration was found as the value of regression coefficient (R2) was 0.999. The accuracy of the drug was ranged in between 98.54–101.80 for all ultraviolet-spectrophotometric methods and was in acceptable range. The percentage RSD values for method precision for all the methods were within the limit of ≤ 2. From the data it was concluded that the methods developed have scope to be applied for quantitative estimation of pure drug of teneligliptin in pharmaceutical dosage form.

Keywords

Ultra Violet-Spectrophotometry, Teneligliptin, Peak minima, AUC technique