Simultaneous Estimation of Sacubitril and Valsartan by RP-HPLC in Bulk and Tablet Dosage Form

Ch.Sakhinamma

RP-HPLC, Sacubitril, Valsartan, Method Validation, ICH Q2(R1)

A new, simple, rapid, precise, and accurate Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Sacubitril and Valsartan in bulk and tablet dosage form. The chromatographic separation was achieved using an Agilent C18 column (4.6 × 150 mm, 5 μm) with the mobile phase comprising Methanol and Acetonitrile (70:30 v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 254 nm using a Shimadzu SPD-20MA system. The retention times for Sacubitril and Valsartan were 2.335 min and 3.400 min, respectively. The method exhibited excellent linearity within the concentration ranges of 10–50 µg/mL for Sacubitril and 20–100 µg/mL for Valsartan, with correlation coefficients (r²) of 0.999 for both. The percentage recoveries were found to be 99.56% and 99.48%, respectively. The %RSD values for repeatability and intermediate precision were below 0.5%, indicating high reproducibility. LOD and LOQ were 2.17 μg/mL and 6.60 μg/mL for Sacubitril, and 0.0372 μg/mL and 0.1125 μg/mL for Valsartan, respectively. The proposed method was validated as per ICH Q2(R1) guidelines and proved suitable for routine quality control analysis of combined dosage forms.

Published Paper   E-Certificate

"Simultaneous Estimation of Sacubitril and Valsartan by RP-HPLC in Bulk and Tablet Dosage Form", JETNR - JOURNAL OF EMERGING TRENDS AND NOVEL RESEARCH (www.JETNR.org), ISSN:2984-9276, Vol.4, Issue 6, page no.a603-a610, June-2026, Available :https://rjpn.org/JETNR/papers/JETNR2606078.pdf

Volume 4 Issue 6, June-2026

Pages : a603-a610

Paper Reg. ID: JETNR_233532

Published Paper Id: JETNR2606078

Downloads: 00065

Research Area: Pharmacy All

Country: Nellore, A.P, India

Published Paper PDF: https://rjpn.org/JETNR/papers/JETNR2606078

Published Paper URL: https://rjpn.org/JETNR/viewpaperforall?paper=JETNR2606078

ISSN: 2984-9276 | IMPACT FACTOR: 9.87 Calculated By Google Scholar | ESTD YEAR: 2023

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.87 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

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