Stability Indicating RP‐HPLC Method for Determination of Valsartan in Pure and Pharmaceutical Formulation

Patro, Saroj Kumar; Kanungo, Sunil Kumar; Patro, V. J.; Choudhury, N. S. K.

doi:10.1155/2010/487197

Cited by 15 publications

(8 citation statements)

References 6 publications

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“…Some methods have been published for simultaneous determination of studied ARA-II-drugs including Spectrophotometry [7], HPLC-DAD [2], HPLC with fluorimetric detection [1] and capillary zone electrophoresis [8,9]. Some stability studies were reported for Losartan [10][11][12][13], Irbesartan [14,15], Valsartan [16][17][18] and Telmisartan [19]. But no published method depends on optimum stress test conditions [20] and it is the first stability study which comprises the four ARA-II compounds together.…”

Section: Introductionmentioning

confidence: 99%

Stability Indicating HPLC Method for Simultaneous Determination of Several Angiotensin-II-Receptor Antagonists in Their Dosage Forms

Elshanawane¹,

Abdel‐Aziz²,

Hafez³

2012

Pharm Anal Acta

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A stability-indicating reversed-phase liquid chromatographic (RP-HPLC) method has been established for simultaneous determination of four angiotensin-II-receptor antagonists (Losartan potassium, Valsartan, Telmisartan and Irbesartan) in the presence of the degradation products generated in studies of forced decomposition. All drug substances were subjected to drastic condition of stress studies involving hydrolysis by acid and base, thermal decomposition by heat at 70°C, oxidation by hydrogen peroxide and photo degradation. Losartan potassium and Valsartan were degraded acidic conditions. Irbesartan was degraded basic conditions. Telmisartan showed good stability against all stress conditions. Successful separation of the drugs from the degradation products was achieved on ACE C18 column (250 mm×4.6 mm, 5 μm) with 65:35 % (v/v) potassium dihydrogen phosphate (0.025 M, pH 6.0): acetonitrile as a mobile phase at flow rate 1.5 ml/min with UV detection at 220 nm. The proposed method was validated in terms of linearity, accuracy, precision and limits of detection and quantitation. Statistical analysis proved the method enabled reproducible and selective quantification of these drugs as the bulk drug and in pharmaceutical dosage forms. Because the method effectively separates the drugs from their degradation products, it can be used as stability-indicating.

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Section: Introductionmentioning

confidence: 99%

Stability Indicating HPLC Method for Simultaneous Determination of Several Angiotensin-II-Receptor Antagonists in Their Dosage Forms

Elshanawane¹,

Abdel‐Aziz²,

Hafez³

2012

Pharm Anal Acta

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“…The pH value in all VAL syrups was not changed significantly during the study period at either temperature. Degradation of VAL in strongly acidic solutions is much faster than under alkaline conditions (23,24), but less acidic solutions do not cause degradation, as can be concluded from the good stability of VAL in Ora ® syrups (pH 4-5) (7,25,26).…”

Section: Valsartanmentioning

confidence: 91%

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Musko

Sznitowska

2014

Acta Pharmaceutica

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Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are oral liquids and pharmacists use commercial dispersing media to compound syrups from an active substance or from tablets available on the market. In many countries ready-to-use dispersing media are not available or refunded, but pharmacists can use other compounded media, providing their compatibility and stability are proven. The aim of this study was to formulate and evaluate the stability of syrups with candesartan cilexetil (1 mg mL-1) and valsartan (4 mg mL-1) extemporaneously prepared using commercial tablets (Diovan® and Atacand®). The following three different suspending media, which could be easily made in a pharmacy, were investigated: V1 - with xanthan gum (0.5 %), V2 - the USP/NF vehicle for oral solution and V3 - the medium based on a simple sucrose syrup. The stability of preparations was studied during 35 days of storage in a dark place at controlled temperature of 25 and 4 °C. During the study, microscopic observation was carried out and pH, viscosity, and concentration of candesartan cilexetil and valsartan were analyzed. Syrups with valsartan prepared with V2 and V3 media were stable for 3 or 4 weeks when stored at 25 °C, while syrups with candesartan were stable for as long as 35 days. For syrups prepared using V1 medium, the 14-day expiry date was not achieved because of microbial deterioration.

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“…Ultra‐performance liquid chromatography (UPLC) using 1.7 μm particles and a suitable system provides a significantly greater resolution while reducing run times and improving sensitivity during the determination of many compounds. Currently, the vast majority of drug determination, including sartans, is performed by applying HPLC with conventional UV detectors (Tables ) . Their widespread application arises from the possibility of separating analyzed compounds from a mixture of other ingredients in the pharmaceutical preparation [e.g., HCT, ramipril (RAM), ENA, AML, nebivolol hydrochloride (NEB), captopril (CAP), and amiloride (AMD)], in the presence of impurities, including degradation products.…”

Section: Methodology For Determining Sartans In Raw Materials Pharmamentioning

confidence: 99%

Analysis of Sartans: A Review

Muszalska

Sobczak

Dołhań

et al. 2014

Journal of Pharmaceutical Sciences

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Stability Indicating RP‐HPLC Method for Determination of Valsartan in Pure and Pharmaceutical Formulation

Cited by 15 publications

References 6 publications

Stability Indicating HPLC Method for Simultaneous Determination of Several Angiotensin-II-Receptor Antagonists in Their Dosage Forms

Stability Indicating HPLC Method for Simultaneous Determination of Several Angiotensin-II-Receptor Antagonists in Their Dosage Forms

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Analysis of Sartans: A Review

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