Identification and characterization of potential impurities of valsartan, AT1 receptor antagonist

Sampath, Alwar; Reddy, Anumula Raghupathi; Yakambaram, B.; Thirupathi, A.; Prabhakar, M. C.; Reddy, Padi Pratap; Reddy, V. Prabhakar

doi:10.1016/j.jpba.2009.05.024

Cited by 26 publications

(16 citation statements)

References 6 publications

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“…Generally, for their qualitative and quantitative analysis isocratic, preparative LC and gradient RP‐HPLC, RP‐UPLC, and SPE–LC–DAD(diode array)–MS/MS methods were successfully applied. The following types of detectors were mainly used: UV and DAD . HPTLC with densitometry and UV detection at λ = 254 nm, λ = 250 nm, or capillary electrophoresi were also utilized.…”

Section: Stability Studiesmentioning

confidence: 99%

Analysis of Sartans: A Review

Muszalska

Sobczak

Dołhań

et al. 2014

Journal of Pharmaceutical Sciences

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Section: Stability Studiesmentioning

confidence: 99%

Analysis of Sartans: A Review

Muszalska

Sobczak

Dołhań

et al. 2014

Journal of Pharmaceutical Sciences

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“…1 H chemical shift was recorded on the δ scale in ppm, relative to tetramethylsilane (TMS) δ 0.00 in ppm.…”

Section: Nmr Spectroscopymentioning

confidence: 99%

Development and validation of stability-indicating RP-HPLC method for determination of Olmesartan medoxomile in pharmaceutical dosage form and identification, characterization of alkaline degradation impurity of Olmesartan medoxomile drug substance as well as drug product

Jain

Chaudhari²,

Surana³

2012

CI&CEQ

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Olmesartan Medoxomil (OLME) belongs to a group of angiotensin II receptor blockers used as an antihypertensive agent and is currently being used for prevention of Hypertension. This paper describes the Validation and development of stability indicating RP-HPLC method for the determination of OLME in the presence of its degradation products generated from forced degradation study and characterization of degradation product (impurity). The assay involved gradient elution of OLME on An LC GC BDS C18 column (250 × 4.5mm, 5-μm particle size) was employed for loading the sample. The mobile phase A consists of 7 ml Triethylamine in 1000 ml water (pH adjusted to 3.0 with orthophosphoric acid) and B contains acetonitrile. Quantification was achieved with photodiode array detection at 257 nm. The chromatographic separation was obtained with a retention time of 6.72 min, and the method was linear in the range 50-150 µg/ml. The method was validated according to the ICH guidelines with respect to linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), specificity and robustness. Impurity found in stressed and stability studies of Olmesartan Medoxomil in both drug substance and drug product are described. This degradation product is identified as 1-(biphenyl-4-ylmethyl)-1H-imidazole-5-carboxylic acid. An Alkaline degradation pathway of Olmesartan medoxomil, for the formation of this degradation product, has been proposed and degradation product was characterized

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“…Spectral data of VAL were obtained in DMSO-d 6 . The chemical shift values are reported in the ı scale, in ppm relative to TMS internal standard (ı 0.00 ppm) for 1 H and relative to the solvent residual peak (ı CDCl 3 77.0 ppm and ı DMSO-d 6 39.5 ppm) for 13 C signals.…”

Section: Instrumentationmentioning

confidence: 99%

“…In view of its wide use, the determination of process and degradation impurities in VAL bulk drug [4][5][6][7][8][9] and drug products [10][11][12] has received much attention. Recently, the group of Krishnaiah reported a UPLC based stability-indicating method for the drug, which included the simultaneous detection and quantification of seven impurities [13].…”

Section: Introductionmentioning

confidence: 99%