Stability Indicating UV Spectrophotometric Methods for the Determination of Nateglinide in Pharmaceuticals

Research Article

Austin J Anal Pharm Chem. 2018; 5(1): 1096.

Stability Indicating UV Spectrophotometric Methods for the Determination of Nateglinide in Pharmaceuticals

Basavaiah K1* and Rajendraprasad N2

¹Department of Chemistry, University of Mysore, Manasagangothri, Karnataka, India

²Postgraduate Department of Chemistry, JSS College of Arts, Commerce & Science, Karnataka, India

*Corresponding author: Kanakapura Basavaiah, Department of Chemistry, University of Mysore, Manasagangothri, Karnataka, India

Received: February 11, 2018; Accepted: March 12, 2018; Published: March 19, 2018

Abstract

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.

Keywords: Nateglinide; Determination; UV Spectrophotometry; Pharmaceuticals; Stability-Indicating

Introduction

Nateglinide (NTG) is chemically known as [N-(trans-4- isopropylcyclohexyl carbonyl)-D-phenylalanine] (Figure 1) [1]. It is a D-phenylalanine derivative lacking either a sulphonylurea orbenzamido moiety and is a novel oral meal-time glucose regulator and has been approved for the treatment of diabetes mellitus [2,3]. This meglitinide derivative works by stimulating the pancreas to release insulin by closing the ATP-dependent potassium channels. The resulting influx of calcium induces insulin secretion. It is rapidly and completely absorbed from the gastrointestinal tract and peak plasma concentration reaches at 0.5-1.0 h. It is metabolized by cytochrome P-450 system to inactive metabolite and eliminated with half-life of 1.4h [4].