Stability indicating UV spectrophotometric methods for the determination of nateglinide in pharmaceuticals

Basavaiah, K. and Rajendraprasad, N. (2018) Stability indicating UV spectrophotometric methods for the determination of nateglinide in pharmaceuticals. Journa of Analytical and pharmacemtical chemistry, 1 (5). pp. 1-8. ISSN 23818913

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Two methods which are simple, rapid and cost-effective are presented for determination of NTG in bulk and tablets using uv-spectrophotometry. Methods are based on measurement of absorbance of drug solution either in 0.1M NaOH at 210 nm (NaOH method) or in 0.1 M HCl at 270nm (HCl method). Beer’s law is obeyed over concentration ranges of 3-54 and 4-72 μg/mL for NaOH method and HCl method, respectively; and corresponding molar absorptivity values are 4.09 ×103 and 3.04 ×103 L/mol/cm. Calculated Sandell sensitivities are 0.0776 and 0.0995 μgcm-2 with NaOH and HCl as diluents, respectively. Limits of detection (LOD) and quantification (LOQ), calculated according to the ICH guidelines are: 0.91 and 2.73μg/mL (NaOH method) and 0.72 and 2.16 μg/mL (HCl method). Intra-day and inter-day accuracy and precision, determined by replicate analyses at three concentration levels, were ≤2% (%RE) and ≤1.63% (%RSD), respectively. Method robustness was assessed by making small changes in the measurement wavelength whereas the ruggedness was tested by inter-analysts and inter-cuvettes variations. Validated methods were applied to the determination of active ingredient in tablets. Drug was subjected to forced degradation via acid and alkali hydrolysis, oxidation, thermolysis and photolysis.

Item Type: Article
Subjects: C Chemical Science > Chemistry
Divisions: Department of > Chemistry
Depositing User: LA manjunath user
Date Deposited: 22 Jan 2021 10:54
Last Modified: 22 Jan 2021 10:54

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