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ISSN 2063-5346
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Sacubitril and Valsartan Analytical Method Development and Validation by RP HPLC in Combined Dosage Form 97/103 mg

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Marina Juliet A, Deepak M, Logeshwari T, Vijey Aanandhi M
» doi: 10.48047/ecb/2023.12.1.318

Abstract

The objective of this study was to describe a simple and selective LC method for the simultaneous dosing of sacubitril and valsartan in tablet form. Materials and methods: The chromatographic separations were optimized by isocratic HPLC on a Thermo Scientific Hypurity C18 (100 mm X 4.6 mm), 5 μm, using a mobile phase consisting of 0.1% orthophosphoric acid and a preparation of 500ml of methanol: tetrahydrofuran 500ml. The mobile phase ratio of solution A and solution B was 65:35 (% v/v), flow rate was 1.4 ml/min and UV detection was performed at 254 nm. Results: The optimized method produced Valsartan and Sacubitril retention times of 4.1 and 5.7 minutes, respectively, with theoretical plate counts and asymmetry within ICH limits. The proposed method has been validated in terms of precision, accuracy, linearity, system suitability, filter validation and solution stability. With Sacubitril, linearity was observed over a concentration range of 10.0-40.0 g/ml (r2 = 0.9992), Valsartan, 10.5-40.0 g/ml (r2 =0.9995) Repeatability analysis showed %RSD less than 2, indicating the method is accurate. Percentile determinations were found to be 99.1% and 99.8%, respectively. This method can be used successfully to evaluate both sacubitril and valsartan, as all statistical evidence supports its efficacy according to ICH criteria. Conclusions: The proposed method is precise, fast, accurate and can be used for routine quality control analysis.

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