alexa Separation and Quantification of Octahydro-1h-Indole-2-Carboxilic Acid and Its Three Isomers by HPLC using Refractive Index Detector
ISSN: 2157-7064

Journal of Chromatography & Separation Techniques
Open Access

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Research Article

Separation and Quantification of Octahydro-1h-Indole-2-Carboxilic Acid and Its Three Isomers by HPLC using Refractive Index Detector

Shaik Jafer Vali1,2*, Saladi Santhi Kumar4, Shakil S Sait3 and Lovleen Kumar Garg3

1United States Pharmacopeia-India Private Limited, Research and Development Laboratory, ICICI Knowledge Park, Hyderabad, India

2Department of Chemistry, Jawaharlal Nehru Technological University, Hyderabad, India

3Dr. Reddy’s Laboratories Ltd, Hyderabad, India

4National institute of pharmaceutical Education and Research, Hyderabad, India

*Corresponding Author:
Shaik jafer vali
Department of Chemistry
Jawaharlal Nehru Technological University
Hyderabad, India
E-mail: [email protected]

Received date: July 13, 2012; Accepted date: August 23, 2012; Published date: August 26, 2012

Citation: Vali SJ, Kumar SS, Sait SS, Garg LK (2012) Separation and Quantification of Octahydro-1h-Indole-2-Carboxilic Acid and Its Three Isomers by HPLC using Refractive Index Detector. J Chromat Separation Techniq 3:136. doi:10.4172/2157-7064.1000136

Copyright: © 2012 Vali SJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Octahydro-1H-indole-2-carboxylic acid is a key starting material for the synthesis of Perindopril and Trandolapril. A rapid, economical, simple, sensitive and reliable stability-indicating reverse phase HPLC method developed and validated for the quantitative determination of all isomers related to Octahydro-1H-indole-2-carboxylic acid and its related substances. The compound is non chromophoric, it has three chiral centers and there is a possibility of four pairs of enantiomers. Refractive index detector was used for the quantification of all its isomers. Optimized mobile phase is 10 mM potassium phosphate buffer with pH-3.0. The C18 column (Inertsil ODS-4, 250 mm×4.6 mm×5 μm) is used as the stationary phase with a mobile phase flow rate of 1.5 mLmin–1 and column temperature maintained at 35°C. The developed method was validated as per ICH guidelines for Accuracy, linearity, range, precision, ruggedness, robustness, solution stability, limit of quantification, and limit of detection. A linear range from LOQ to 150% performed for the analyte and its three isomers. The correlation coefficient obtained for all the isomers was more than 0.999. The recoveries obtained for all isomers were found in between 93.9% and 107.9%. The detection limit for all the isomers were about 0.006 mg/mL and the quantification limits were in between 0.022 mg/mL to 0.024 mg/mL respectively. The proposed method can be successfully applied for the quantification of the three isomers in Octahydro-1H-indole-2-carboxylic acid and provides a simple and cost effective quality control tool for routine analysis.

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