Development and validation of a simple stability indicating UPLC method for the determination of repaglinide in pharmaceuticals

Xavier, C.M. and Basavaiah, K. (2013) Development and validation of a simple stability indicating UPLC method for the determination of repaglinide in pharmaceuticals. Thai Journal of Pharmaceutical Sciences, 37 (2). pp. 84-94.

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Abstract

A simple, precise and accurate stability-indicating isocratic reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of repaglinide (RPG) in bulk drug and in its tablets. The method was developed using Waters Aquity BEH C18 (100 � 2.1) mm, 1.7 μm column with mobile phase consisting of a mixture of potassium dihydrogen phosphate buffer of pH 3.2 and acetonitrile (40:60 v/v). The total run time for the assay was only 4 min. The eluted compound was detected at 245 nm with an UV detector. The standard curve of mean peak area versus concentration showed an excellent linearity over a concentration range 0.1-750 μg ml -1 RPG with regression coefficient (r) value of 0.9997. The limit of detection (S/N = 3) was 0.03 μg ml -1 and the limit of quantification (S/N = 10) was 0.1 μg ml -1 . With three quality control concentrations of 100, 200 and 300 μg ml -1 , accuracy and precision of the assay were satisfactory. Both withinday and between-day RSD were less than 1.0%. The method was validated by the determination of RPG in tablets and the percent of the label claim was 100 ± 2%. The accuracy of the method was further ascertained by recovery studies via standard addition procedure and the recoveries obtained were 96.6-100.9%. Forced degradation of the bulk sample was conducted in accordance with the ICH guidelines. Acid and base hydrolysis, oxidative, thermal stress and photolytic degradation were used to assess the stability indicating power of the method. RPG was found to degrade significantly in acidic and basic stress conditions and stable in oxidative, thermal and photolytic conditions. The degradation products were well resolved from main peak proving the stability-indicating power of the method.

Item Type: Article
Uncontrolled Keywords: accuracy, acetonitrile, article, bulk density, concentration response, drug degradation, drug determination, drug hydrolysis, drug selectivity, drug solubility, drug stability, drug structure, drug synthesis, eurepa 1, eurepa 2, limit of detection, limit of quantitation, oxidative stress, pH, photolysis, placebo, potassium dihydrogen phosphate, quality control, repaglinide, reverse phase ultra performance liquid chromatography, temperature stress, ultra performance liquid chromatography, ultraviolet detector, unclassified drug, validation process
Subjects: C Chemical Science > Chemistry
Divisions: Department of > Chemistry
Depositing User: Arshiya Kousar
Date Deposited: 11 Nov 2019 06:52
Last Modified: 11 Nov 2019 06:52
URI: http://eprints.uni-mysore.ac.in/id/eprint/9638

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