International Journal of Drug Development and Research

Keywords

Gliclazide, Visible spectrophotometry, Tablets, Validation.

INTRODUCTION

Gliclazide(GCZ) is a specific type of an antidiabetic drug most commonly used for type2 diabetes mellitus.[1].Chemically it is 1-(1- azabicyclo(3,3,0)octyl)-3-(p-tolylsulphonylurea)[2]. Literature review revealed very few analytical methods including Radioimmunoassay[3], Gas chromatography[4] ,HPLC[5,6], Evaporative Light Scattering[7], Mass spectroscopy[8] and LC-MS[9] for quantification of GCZ in pharmaceutical dosage forms. The present work deals with the estimation of GCZ in tablets by formation of colouredcomplexwith 1, 10-phenanthroline and ferric chloride having max at 512nm(Figure 1). Spectrophotometric parameters are established for standardization of the method including statistical analysis of data.

EXPERIMENTAL

Instrumentation: All spectral and absorbance measurement was made on Shimadzu UV-VIS spectrophotometer-1650.

Reagents: 1, 10-phenanthroline (0.1%w/v), Ferric chloride(5%w/v).All reagents used were of analytical grade .

Preparation ofstandard solution: A 1mg/ml stock solution of GCZ was prepared by dissolving 50 mg of drug in 50 ml of methanol.

Sample Preparation: Twenty tablets were weighed. A quantity equivalent to 50 mg of GCZ was weighed accurately, transferred to a beaker, dissolved in methanol, filtered through whatmann filter paper No.1 into a 50ml volumetric flask and made up to volume with methanol to get a concentration of 1 mg/ml.

Assay:

Aliquots of GCZ were pipetted out into a series of 10ml volumetric flasks. To each flask 1ml of ferric chloride and 1ml of 1,10-phenanthroline were added and made up to volume with methanol. The absorbance of the orangeredcolouredchromogen was measured at 512nm against the reagent blank. The amount of GCZ was computed from the calibration curve obtained by plotting concentration versus absorbance.

Sample analysis: Pharmaceutical formulation of GCZ was successfully analyzed by the proposed method.Appropriate aliquots were subjected to the above method and the amount of GCZ was determined from the calibration curve.The results of sample analysis are furnished in Table-2.

RESULTS AND DISCUSSION

The optical characteristics such as absorption maxima,Beer’s law limits,molar absorptivity and Sandell’s sensitivity are furnished in Table-1.The regression characteristics like slope(m),intercept(c),correlation coefficient( r),percent relative standard deviation(% RSD) and standard error (SE)obtained from different concentration were calculated and the results are summarised in Table 1..

To study the accuracy and reproducibility of the proposed method,recovery experiments were carried out by adding a known amount of drug to preanalyzed sample and the percentage recovery was calculated.The results are furnished in Table 2.The results indicate that there is no interference of other ingredients present in the formulations.Thus, the proposed method is simple, sensitive, precise, accurate and reproducible and useful for the routine determination of GCZ in bulk drug and its pharmaceutical dosage forms.

ACKNOWLEDGEMENTS

We are thankful to the Department of Pharmaceutical Chemistry, Madras Medical College, Chennai-03, for providing the instrumentation and laboratory facilities.

Tables at a glance

Table 1 Table 2

Figures at a glance

Figure 1

References

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