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Comparison of UV spectrophotometry and high performance liquid chromatography methods for the determination of repaglinide in tablets.

Title: Comparison of UV spectrophotometry and high performance liquid chromatography methods for the determination of repaglinide in tablets.
Authors: Dhole SM; Department of Pharmaceutical Chemistry, Sharad Pawar College of Pharmacy, Nagpur, Maharashtra, India.; Khedekar PB; Amnerkar ND
Source: Pharmaceutical methods [Pharm Methods] 2012 Jul; Vol. 3 (2), pp. 68-72.
Publication Type: Journal Article
Language: English
Journal Info: Publisher: Medknow Publications and Media Pvt Country of Publication: India NLM ID: 101580584 Publication Model: Print Cited Medium: Print ISSN: 2229-4708 (Print) Linking ISSN: 22294708 NLM ISO Abbreviation: Pharm Methods Subsets: PubMed not MEDLINE
Imprint Name(s): Original Publication: Mumbai : Medknow Publications and Media Pvt., [2010]-
Abstract: Background: Repaglinide is a miglitinide class of antidiabetic drug used for the treatment of type 2 diabetes mellitus. A fast and reliable method for the determination of repaglinide was highly desirable to support formulation screening and quality control.; Objective: UV spectrophotometric and reversed-phase high performance liquid chromatography (RP-HPLC) methods were developed for determination of repaglinide in the tablet dosage form.; Materials and Methods: The UV spectrum recorded between 200 400 nm using methanol as solvent and the wavelength 241 nm was selected for the determination of repaglinide. RP-HPLC analysis was carried out using Agilent TC-C18 (2) column and mobile phase composed of methanol and water (80:20 v/v, pH adjusted to 3.5 with orthophosphoric acid) at a flow rate of 1.0 ml/min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization (ICH) guidelines.; Results: The developed methods illustrated excellent linearity (r(2) > 0.999) in the concentration range of 5-30 μg/ml and 5-50 μg/ml for UV spectrophotometric and HPLC methods, respectively. Precision (%R.S.D < 1.50) and mean recoveries were found in the range of 99.63-100.45% for UV spectrophotometric method and 99.71-100.25% for HPLC method which shows accuracy of the methods.; Conclusion: The developed methods were found to be reliable, simple, fast, accurate and successfully used for the quality control of repaglinide as a bulk drug and in pharmaceutical formulations.
References: Anal Sci. 2003 Dec;19(12):1675-7. (PMID: 14696936); J Pharm Biomed Anal. 2007 Apr 11;43(5):1831-5. (PMID: 17240100); Indian J Pharm Sci. 2010 Mar;72(2):240-4. (PMID: 20838532)
Contributed Indexing: Keywords: Method validation; RP-HPLC; quantitative analysis; repaglinide
Entry Date(s): Date Created: 20130620 Date Completed: 20130620 Latest Revision: 20211021
Update Code: 20260130
PubMed Central ID: PMC3658086
DOI: 10.4103/2229-4708.103875
PMID: 23781481
Database: MEDLINE

Journal Article