TITLE

Determination of Repaglinide in Pharmaceutical Formulations by RP-HPLC Method

AUTHOR(S)
Rani, A. Prameela; Sekaran, C. Bala; Archana, N.; Teja, P. Siva; Aruna, B.
PUB. DATE
October 2009
SOURCE
Journal of Applied Sciences Research;Oct2009, Vol. 5 Issue 10, p1500
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
A new Reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of repaglinid e in pharmaceutical formulations. Optimum separation was achieved in 12 minutes us ing C18 column (250 mm × 4.6 mm, i.d., particle size 5 mm), and elution was accomplished using a mobile phase (1mL/min). Detection was carried out using a UV detector set at 245 nm. A linear relationship between mean peak area and concentration of repaglinide was observed in the ran g e 0.5-5 μg/mL, with a detection limit of 0.275 μg/mL and a quantification limit of 0.833 μg/mL. Intra-day and Inter-day precision, and accuracy of the method have been established according to the current ICH guidelines. The developed method was successfully applied to the determination of repaglinide in pharmaceutical formulations. The results were statistically compared with the reference method (UV method) by applying Student's t-test and F-test. Accuracy, evaluated by means of the recovery method, was in the range 99.75 ± 0.55 to 100.73 ± 0.34 , with precision (RSD) 0.88%. No interference was observed from the coformulated substances . The propos ed method was success fully employed for the determination of repaglinide in various pharmaceutical preparations.
ACCESSION #
45587041

 

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