Stability Indicating Rp-HPLC Method for Simultaneous Estimation of Sacubitril and Valsartan in Bulk and Combined Pharmaceutical Dosage Form

Ahmed, Muqhtar

doi:10.20959/wjpps20174-8965

Cited by 8 publications

(3 citation statements)

References 3 publications

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“…It is interesting to observe HPLC had been continuously used in development of stability indicating studies of sacubitril and valsartan ( Ahmed et al., 2017 ; Patel et al., 2017 ; Mishara et al., 2017 ; Naazneen and Sridevi, 2017 ; Jyothi and Umadevi, 2018 ; Moussa et al., 2018 ). Various combinations of mobile phases were used to achieve better separation for sacubitril, valsartan and their impurities.…”

Section: Stability Indicating Assaysmentioning

confidence: 99%

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

Chew

Khor

Lim

2021

Heliyon

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Stability indicating assay describes a technique which is used to analyse the stability of drug substance or active pharmaceutical ingredient (API) in bulk drug and pharmaceutical products. Stability indicating assay must be properly validated as per ICH guidelines. The important components in a stability indicating assay include sensitivity, specificity, accuracy, reliability, reproducibility and robustness. A validated assay is able to measure the concentration changes of drug substance/API with time and make reliable estimation of the quantity of the degradation impurities. The drug substance is separated and resolved from the impurities. Pros and cons of HPLC, GC, HPTLC, CE and SFC were discussed and reviewed. Stability indicating assay may consist of the combination of chromatographic separation and spectroscopic detection techniques. Hyphenated system could demonstrate parallel quantitative and qualitative analysis of drug substances and impurities. Examples are HPLC-DAD, HPLC-FL, GC-MS, LC-MS and LC-NMR. The analytes in the samples are separated in the chromatography while the impurities are chemically characterised by the spectroscopy in the system. In this review, various chromatographic methods which had been employed as stability indicating assays for drug substance and pharmaceutical formulation were systematically reviewed, and the application of hyphenated techniques in impurities characterisation and identification were also discussed with supporting literatures.

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Section: Stability Indicating Assaysmentioning

confidence: 99%

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

Chew

Khor

Lim

2021

Heliyon

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“…A freshly prepared mixture of acetonitrile and citrate buffer (pH 3.5) (60:40 v/v) was used as the mobile phase. The flow rate of the mobile phase was maintained at 1.0 mL/min, and UV detection was set at 255 nm [19].…”

Section: Apparent Equilibrium Solubility Studymentioning

confidence: 99%

Combining Co-Amorphous-Based Spray Drying with Inert Carriers to Achieve Improved Bioavailability and Excellent Downstream Manufacturability

Zhang

Gao

et al. 2020

Pharmaceutics

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It is crucial to improve poorly water-soluble orally administered drugs through both preclinical and therapeutic drug discovery. A co-amorphous formulation consisting of two low molecular weight (MW) molecules offers a solubility/dissolubility advantage over its crystalline form by maintaining their amorphous status. Here, we report on a co-amorphous solid dispersion (SD) system that includes inert carriers (lactose monohydrate or microcrystalline cellulose) and co-amorphous sacubitril (SAC)-valsartan (VAL) using the spray drying process. The strong molecular interactions between drugs were the driving force for forming robust co-amorphous SDs. Our system provided the highest solubility with more than ~11.5- and 3.12-times solubility increases when compared with the physical mixtures. Co-amorphous lactose monohydrate (LM) SDs showed better bioavailability of APIs (~356.27.8% and 154.01% for the relative bioavailability of LBQ 657 and valsartan, respectively). Co-amorphous inert carrier SDs possessed an excellent compressibility for the production of a direct compression pharmaceutical product. In conclusion, these brand-new co-amorphous SDs could reduce the number of unit processes to produce a final pharmaceutical product for downstream manufacturability.

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“…The primary matter of valsartan, valeryl 4-hydroxy valsartan, has no medicine activity. Literature search reveals that only two analytical methods were reported for simultaneous estimation of sacubitril and valsartan from rat plasma using LC-MS/MS and from a synthetic mixture using HPLC [12][13][14][15][16][17][18][19][20]. Hence a simple, rapid, sensitive and accurate stability indicating HPLC method was developed for the simultaneous estimation of sacubitril and Valsartan from rat plasma (Figures 1 & 2).…”

Section: Drug Profilementioning

confidence: 99%

Development and Validation of A RP- HPLC Method for the Simultaneous Estimation of Valsartan and Sacubitril in Rat Plasma

Anjaneyulu

2018

GJPPS

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A basic precise selective, sensitive isocratic technique was developed and valid for the quantitative synchronic estimation of Sacubitril and Valsartan drug in rat plasma was by RP- HPLC system. The chromatographic activity separation was administrated out on Intersil C18 (250 x 4.6mm, 5μm) column with a mix of acetonitrile: di-potassium hydrogen phosphate, pH 3.0 adjusted with Phosphate buffer (30:70%v/v) as mobile part. The analytes were eluted with a rate of flow of 0.8ml/min and at a wavelength of 371nm of UV detection. The strategy was valid for precision, accuracy, linearity, Limit of detection, Limit of Quantification, Ruggedness following the ICH guidelines. The retention time was 10.725min and 15.366min and the system suitableness results was 99.95% and 100.24% for sacubitril and valsartan respectively. Linearity contemplate was completed between 100-500μg/ml and 5μg-25μg/ml, linear regression coefficient was observed to be 0.999 and the percentage recovery varies from 98-102% of Sacubitril and valsartan. No interference from any part of bulk and pharmaceutical dosage form was determined. All the parameters of validation are found to be at intervals within the vary that confirms the quality of the strategy for the determination of Sacubitril and Valsartan.

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Stability Indicating Rp-HPLC Method for Simultaneous Estimation of Sacubitril and Valsartan in Bulk and Combined Pharmaceutical Dosage Form

Abstract: to the label claim of the marketed tablet formulation followed by subjecting the drug to hydrolysis, oxidation, photolysis and thermal degradation studies. The drug was found to degrade extensively in acidic 0

Cited by 8 publications

References 3 publications

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

Combining Co-Amorphous-Based Spray Drying with Inert Carriers to Achieve Improved Bioavailability and Excellent Downstream Manufacturability

Development and Validation of A RP- HPLC Method for the Simultaneous Estimation of Valsartan and Sacubitril in Rat Plasma

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