Table 3 presents the accuracy data obtained for the method. Robustness Robustness selleck chemicals of the method was investigated by varying the chromatographic conditions such as change of flow rate (�� 10%), organic content in the mobile phase (�� 2%), wavelength of detection (�� 5%), and pH of buffer in the mobile phase (�� 0.2%). Robustness of the developed method was indicated by the overall % RSD between the data at each variable condition. The observed RSD was 1.47% for the flow rate change, 0.96% for the organic content change, 0.37% for the detection change, and 0.74% for the pH of mobile phase change. In all the conditions the RSD was < 2%, indicating a robust method. Stability The solution stability of cefdinir was carried out by leaving the test solutions of the sample and reference standard in tightly capped volumetric flasks for 24, 48, and 72 hours.
The results were compared with those obtained from freshly prepared standard solutions, and calculation of RSD. The RSD values of the assay of cefdinir during solution stability experiments were within 2%. The RSD observed was 0.86, 1.27 and 1.64% at 24, 48, and 72 hours respectively. Degradation behavior HPLC studies on cefdinir, under different stress conditions, suggested the following degradation behavior [Table 1]. The drug gradually decreased with time, on heating at 60��C, in 0.1 M HCl [Figure 2c]. The rate of hydrolysis in acid was slower as compared to that of alkali or oxidation [Figure 2d]; 20.14% of the drug degradation was observed with acid. The drug was found to be highly labile to alkaline hydrolysis.
The reaction in 0.1 N NaOH at 60��C was so fast that 48.83% of the drug was degraded in 60 minutes [Figure 2d]. Cefdinir proved labile to hydrogen peroxide (3%) at 60��C. After refluxing at 60��C for 60 minutes, 31.20% of the drug was degraded [Figure 2e]. The drug was comparatively stable to thermal degradation. Only 20.12% of the drug was degraded after refluxing at 60��C for 60 minutes, [Figure 2f]. No major degradation product was observed after exposure of the drug solution to UV light for 24 hours. Only minor degradation (8.55%) was observed. [Figure 2g]. Figure 2 Representative chromatograms of cefdinir for the stability method. (a) Blank, (b) Untreated stock solution, (c) Acid hydrolysis, (d) Base hydrolysis, (e) Oxidation, (f) Thermal degradation CONCLUSION Thus the developed HPLC method for determination of cefdinir is simple, precise, accurate, and stability indicating.
Statistical analysis proves that the method is reproducible and selective for the analysis of cefdinir in bulk drugs. AV-951 As the method efficiently estimates cefdinir in the presence of its degradation products, it can be employed as a stability indicating method and can also be successfully applied for the assay of cefdinir in the bulk drug and in pharmaceutical dosage forms in the pharmaceutical industry.