VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DROTAVERIN.HCL & ACECLOFENAC IN BULK AND FORMULATION
RESULTS AND DISCUSSION
Correlation coefficient of the linearity study was found to R2 =0.998 and 0.999 with linear regression equation Y=46573X+5706 for Drotaverin and Y=161434X-32034 for Aceclofenac, which proves the method was linear.
As the recovery results are found between 98.0% to 102.0%, the study proves that the
Method is accurate for the estimation.
The %RSD of areas from six preparations precision level should not be more than 2.0%.
Table 2: Observation of Specificity data of the proposed method
Table 3: System suitability results
Table 4: Linearity results for Aceclofenac and Drotaverin
Fig 4: Calibration curve of Drotaverin
Fig 5: Calibration Curve of Aceclofenac
Table 5: Precision results for Aceclofenac
Table 6: Precision results for Drotaverin
Table 7: Results for Robustness
A simple, precise, robust and cost effective stability indicting RP-HPLC method has been developed & validated for the analysis of Drotaverine and Acceclofenac API. Based on peak purity results, obtained from the analysis of samples using described method, it can be concluded that the absence of co-eluting peak along with the main peak of Drotaverine &Acceclofenac indicated that the developed method is specific for the estimation of Drotaverine &Acceclofenac. Further the proposed RP-HPLC method has excellent sensitivity, precision and reproducibility. Even though no attempt has been made to identify the degraded products proposed method can be used as a stability indicating method for assay of Drotaverine and Acceclofenac in commercial formulations.
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