DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF A COMBINATION OF PRAVASTATIN SODIUM AND VALSARTAN BY REVERSED PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

ABSTRACT Objective: The main aim of this study was to develop and validate analytical methods for an estimation of a combination of two different drugs by high performance liquid chromatography (HPLC). The objective of this study was to demonstrate that the method is suitable for its intended purpose as it is stated in ICH guidelines. The method was validated for linearity, precision, accuracy, specificity, and limit of detection, limit of quantification, and robustness. Methods: Various parameters were analyzed for a drug combination according to standard procedures. The aim of this study was to develop a simple, accurate, and precise HPLC method for the analysis of the combination of pravastatin sodium (PVS) and valsartan using mobile phase and commonly employed Nucleodur C column with ultraviolet detector at 238 nm. The typical chromatogram of PVS and valsartan was shown in Fig. 5. The optimal retention time was found to be 4.815 minutes for PVS and 15.518 minutes for valsartan. 18 Result: The result of linearity for both PVS and valsartan was given in Tables 1 and 2, respectively. The results are shown in Tables 3 and 4. The repeatability refers to the use of the analytical procedure within a laboratory over a short period of time using the same analyst with the same equipment and is expressed as the % relative standard deviation (RSD). The results of method precision are shown in Table 4. The % RSD for method precision was found to be 0.79 for PVS and 0.32 for valsartan. The results are shown in Tables 5 and 6. The ruggedness of analytical method is the degree of reproducibility of the test results obtained by the same samples under a variety of conditions such as different laboratories, different analysts, different instruments, different lots of reagents, and different days. The assay result indicated that the method was capable with a high precision. The results of % RSD prove the ruggedness of developed method as shown in Tables 7 and 8. Conclusion: The proposed reversed phase-HPLC method enables the determination of PVS and valsartan because of a good separation of chromatographic peaks (Fig. 5). The method can be used successfully for the analysis of PVS and valsartan in combination. Keywords: Pravastatin sodium, Valsartan, High performance liquid chromatography, Validation.