International Journal of Pharmaceutics & Drug Research

Sonali Baranwal, Mrs. Ketkee Mandawar, Dr. Om Prakash Agrawal

ABSTRACT

This study comprehensively deals with development of a novel and efficient analytical method for the determination of Gliclazide using hydrotopy & stability indicating HPLC. All the methods for examining different parameters were performed according to standard procedure. The correlation coefficients of Gliclazide were found to be 0.999. At 80 & 100% recovery level the % recovery was observed to be 99.00±0.514 & 98.37±1.451 respectively while for 120% recovery level maximum recovery of 99.37±0.406 was seen. The % RSD for 80,100 & 120 recovery level was estimated to be 0.519, 1.475 & 0.409 respectively. The % RSD value was found to be 0.071, 0.301, 0.039, 0.053 for repeatability, day to day, analyst to analyst and reproducibility indicating that the method is precise. The system suitability parameters revealed that hat tailing factor & retention time have value of 0.987±0.020 & 4.204±0.003. The no. of theoretical plates were noted to be 2358.333± & 67.669. Result of linearity of Gliclazide revealed slope & intercept as 50.23 & 9.691. Further at 80, 100 & 120 % recovery level the % Mean±SD was observed to be 98.95±1.159, 99.30 ±0.590 & 99.25±0.485 respectively. Results of precision shown that repeatability, day to day & analyst to analyst variation have % Mean±SD of 99.342±0.240, 99.542±0.071& 99.403±0.074. The robustness of method was calculated as 99.539±0.054. The LOD & LOQ was estimated to be 0.85 & 2.35. The tablet formulation analysis revealed that in 60 mg label claim drug, about 59.78 mg of drug was found. The % Assay & % RSD was noted to be 99.63 & 0.110 respectively. The maximum degradation of drug which is 13.17% with minimum drug recovery of 86.65 was seen in acidic conditions. Thus the proposed approach effectively solubilize Gliclazide & prevents degradation of drug products.

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