ICH-Compliant HPTLC Method for the Quantitative Determination of Sacubitril and Valsartan in Pharmaceutical Tablets

The multiple sample analysis of Sacubitril (SAC) and Valsartan (VAL) in raw materials of drugs and tablets as pharmaceutical products was developed and validated through advanced thin-layer chromatographic procedures. This method was characterized to be efficient, reliable, repeatable, as well as being user-friendly. The target compounds were separated using aluminum sheets that had previously been coated with silica gel 60 F254 and uses a toluene, ethyl acetate, formic acid and triethylamine solvent mixture in order to accomplish its separation, where toluene was used in a triethylamine ratio of 7:3: 0.1:0.3 v/v/v/v respectively. The CAMAG LINOMAT V applicator was used to apply sample bands, the chromatograms scanned by means of the CAMAG TLC Scanner III. Collection and analysis of the data was processed with WinCATS software 1.4.3. SAC and VAL produced well-differentiated retention factor (Rf) values of 0.66 and 0.72, respectively. Throughout the analysis, methanol was used as the diluting medium. The developed method was validated following the ICH Q2(R1) standards, evaluating key parameters such as calibration curve linearity, recovery, reproducibility, and method consistency. Excellent correlation coefficients were observed, with R² values of 0.9977 for SAC and 0.9947 for VAL, confirming linear response within the tested range. Accuracy assessments via recovery at 50%, 100%, and 150% levels showed average retrieval rates of 99.03% for SAC and 100.74% for VAL. The repeatability of the technique, reflected by %RSD values, was found to be 0.716% for SAC and 0.465% for VAL. Further robustness testing through intra-day and inter-day variability studies yielded %RSD figures of 0.582 and 0.149 for SAC, and 0.466 and 0.416 for VAL, verifying the method's stability and dependability across different testing conditions.