A new high performance liquid chromatography method was developed and validated for the quantitation of Cilnidipine and Valsartan in pharmaceutical formulations. Determination was performed using an ODS C18, 250mm x 4.6mm, 5μm column, a mobile phase containing Methanol: Water (85:15) pH 3 adjusts with ortho-phosphoric acid in isocratic flow rate 1.0 mLmin-1. The method was validated with respect to linearity, precision, robustness, and accuracy. The calibration graphs ranged from 1-5 μg/mL in Cilnidipine and 8-40 μg/mL Valsartan Intraand interday relative standard deviation values for the standard solutions were 0.5%, 1.64% and 0.22%, 1.62 %. Robustness of relative standard deviation values was 0.334, 0.101 respectively. Total recoveries of Cilnidipine and Valsartan from the laboratory prepared mixtures were 98.94 % and 99.04 % respectively.

http://www.eurasianjournals.com/pdf-63221-15334?filename=Simultaneous Estimation.pdf

Simultaneous Estimation of Cilnidipine and Valsartan by RP-HPLC in Tablet Formulation

Objective: The thermal behavior of two antihypertensive drugs: Valsartan (VAL) and Losartan potassium (LOS) was investigated using different thermal techniques. These include thermogravimetry (TGA), derivative thermogravimetry (DTG) and differential scanning calorimetry (DSC). Methods: Thermogravimetric data obtained from first step of decomposition of valsartan and losartan allowed the determination of kinetic parameters such as activation energy (Ea), frequency factor (A), order of reaction (n) and enthalpy of decomposition (∆H). The purity of valsartan and losartan were determined by differential scanning calorimetry. Results: The thermal degradation of losartan and valsartan was followed a first-order kinetic behavior and evaluation of the relative thermal stabilities showed that LOS is more thermally stable than VAL. The decomposition modes were investigated and the fragmentation pathway of losartan was taken as example, to correlate the thermal decomposition with mass spectrometry. The purity of valsartan and losartan determined by differential scanning calorimetry was found to be 99.84 % and 99. 91 %, respectively, which was in good agreement with the pharmacopoeial results. Conclusion: Thermal analysis justifies its application in quality control of pharmaceutical compounds due to its simplicity, sensitivity and low operational costs.

Investigation on thermal stability and purity determination of two antihypertensive drugs, valsartan and losartan potassium

Valsartan (VAL) is an orally active angiotensin-II receptor type-I antagonist. VAL is available alone in dosage form as well as multicomponent formulation with various antihypertensive drugs like nifedipine, hydrochlorothiazide, ramipril, amlodipine and nebivolol hydrochloride, for the management of hypertension. The present investigation assesses the various approaches for analysis of VAL in bulk drug as well as formulated products. A concise review represents the compilation and discussion of about more than 90 analytical methods which includes HPLC, HPTLC, capillary electrophoresis, electrochemical methods and UV-Spectrophotometry methods implemented for investigation of VAL in biological matrices, bulk samples and in different dosage formulations. The review describes the percentage utilization of the various approaches for analysis of VAL. The statistical data regarding the utility of these methods for estimation of VAL published during 2001 to 2016 have been included.

A Concise Review on Analytical Profile of Valsartan

Valsartan (VAL) and losartan potassium (LOS) are antihypertensive drugs, which are closely related in structure. Both drugs were subjected to stress conditions of hydrolysis (in acidic, neutral and alkaline media), oxidation (using hydrogen peroxide), dry heat and air. A reversed phase high performance liquid chromatographic method (RP-HPLC) was established by using acetonitrile: phosphate buffer (0.02M, pH 3.5), (60: 40 v/v) as a mobile phase at flow rate of 1.5 ml/ min and detection at 225 nm. Several factors were studied under the different experimental stress conditions. These factors include reagents concentrations, the applied temperature during stress testing and time of reaction. The degradation studies indicated that LOS is highly susceptible to oxidation, while VAL is very sensitive to acid hydrolysis and exhibits higher sensitivity to alkaline medium than LOS. The two drugs showed nearly the same stability under neutral hydrolysis. The RP-HPLC method was validated according to the ICH guidelines; the linearity range is 8-120 and 10-100 μg/mL for VAL and LOS, respectively; precision, accuracy, robustness, ruggedness, specificity were also evaluated. Thermal analysis of the two drugs was achieved in hot air oven and results show that valsartan is less thermally stable than losartan. The proposed RP-HPLC method is simple, accurate, reproducible, stability-indicating and suitable for routine determination of VAL or LOS in bulk and dosage forms.

Application of a rp-hplc method for comparative study on the degradation behavior of two angiotensin ii receptor antagonists, valsartan and losartan potassium

High-performance liquid chromatographic analysis of angiotensin II receptor antagonist valsartan using a liquid extraction method

A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Valsartan in tablet dosage form. The method employed, Phenomenox C18, 5µm,25cm x 4.6 mm i.d. column in isocratic mode, with mobile phase of methanol & phosphate buffer pH 3.0 in ratio of 65:35(v/v) . The flow rate was 1mL min -1 and effluent was monitored at 210 nm. Retention time was found to be 6.22 min. The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 10- 100 µg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.02 and 0.06 µg/ml respectively. No chromatographic interference from tablet excipients was found. The proposed method was successfully used for estimation of

/pdf/stability-indicating-rp-hplc-method-for-the-estimation-of-2rszdgmpoe.pdf

Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form

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Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form