Open AccessGradient HPLC method development and validation for Simultaneous estimation of Rosiglitazone and Gliclazide.
Author(s) -
Uttam Singh Baghel,
Birendra Shrivastava,
D. Selva Kumar,
Anand Prasad Tiwari
Publication year - 2012
Publication title -
asian pacific journal of tropical disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.208
H-Index - 33
ISSN - 2222-1808
DOI - 10.1016/s2222-1808(12)60259-x
Subject(s) - gliclazide , rosiglitazone , chromatography , gradient elution , dosage form , chemistry , high performance liquid chromatography , acetonitrile , potassium , diabetes mellitus , medicine , receptor , endocrinology , biochemistry , organic chemistry
Objective: The aim of present work was to develop a gradient RP-HPLC method for simultaneous\udanalysis of rosiglitazone and gliclazide, in a tablet dosage form. Method: Chromatographic\udsystem was optimized using a hypersil C18 (250mm x 4.6mm, 5毺 m) column with potassium\uddihydrogen phosphate (pH-7.0) and acetonitrile in the ratio of 60:40, as mobile phase, at a flow\udrate of 1.0 ml/min. Detection was carried out at 225 nm by a SPD-20A prominence UV/Vis detector.\udResult: Rosiglitazone and gliclazide were eluted with retention times of 17.36 and 7.06 min,\udrespectively. Beer’s Lambert ’s Law was obeyed over the concentration ranges of 5 to 70 毺 g/ml\udand 2 to 12 毺 g/ml for rosiglitazone and gliclazide, respectively. Conclusion: The high recovery\udand low coefficients of variation confirm the suitability of the method for simultaneous analysis\udof both drugs in a tablets dosage form. Statistical analysis proves that the method is sensitive and\udsignificant for the analysis of rosiglitazone and gliclazide in pure and in pharmaceutical dosage\udform without any interference from the excipients. The method was validated in accordance with\udICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and\udreproducible