VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DROTAVERIN.HCL & ACECLOFENAC IN BULK AND FORMULATION

 

 

RESULTS AND DISCUSSION
Linearity
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.
Accuracy
As the recovery results are found between 98.0% to 102.0%, the study proves that the
Method is accurate for the estimation.
Precision
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

Precision results for Aceclofenac

Table 6: Precision results for Drotaverin

Precision results for Drotaverin

Table 7: Results for Robustness

Results for Robustness

CONCLUSION
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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