Himaja M et al /Int.J. ChemTech Res. 2016,9(1),pp 142-146.
Table 2 Accuracy results
Lev el | Area | Hydralazine HCl added ( mg) | Hydralazine HCl recovered ( mg) | % Recovery | Mean % Recovery | % RSD |
---|---|---|---|---|---|---|
50% | 1177.1950 | 0.1004 | 0.0986 | 98.2 | 99.9 | 1.5 |
1175.1650 | 0.1004 | 0.0984 | 98.0 | |||
1176.7700 | 0.1004 | 0.0986 | 98.2 | |||
100 % | 2431.5354 | 0.2008 | 0.2036 | 101.4 | ||
2427.3900 | 0.2008 | 0.2033 | 101.2 | |||
2441.7500 | 0.2008 | 0.2045 | 101.8 | |||
150 % | 3597.0950 | 0.3012 | 0.3012 | 100.0 | ||
3603.7050 | 0.3012 | 0.3018 | 100.2 | |||
3598.9750 | 0.3012 | 0.3014 | 100.1 |
The sensitivity of the developed method is associated with Limit of detection (LOD) and Limit of quantification (LOQ). The LOQ and LOD were determined based on signal-to-noise ratios and were determined using an analytical responses of 10 and three times the background noise, respectively. The LOQ was found to be 0.3 ppm with a % R.S.D. of 4.15 (n = 6) and the LOD for hydralazine hydrochloride was found to be 0.10 ppm which confirms high sensitivity of the developed method. The chromatogram of standard under the optimized condition gives a symmetrical single peak well separated from the solvent front (Figure 2). Hence, the proposed method is selective and specific.
Figure 2 Standard chromatogram
Specific and sensitive HPLC method has been developed for the quantification of hydralazine hydrochloride and validated. All the parameters satisfactorily meet the criteria as per ICH guidelines for method validation. Satisfactory results were obtained for the recovery of the three drugs and were in good agreement with the label claims indicating that both the proposed techniques can be used for the quantification in routine quality control analysis of pharmaceutical dosage forms.
The authors are highly thankful to VIT University, Vellore, Tamil Nadu and for Strides Arcolab, Bangalore for providing facilities to carry out the work.
Himaja M et al /Int.J. ChemTech Res. 2016,9(1),pp 142-146.
*****