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Stability Indicating RP-HPLC Method for Quantification of Impurities in Valsartan and Hydrochlorothiazide FDC Tablet Dosage Form  [PDF]
Hari Kishan Reddy Ganthi, Raveendra Reddy P, Young Jun Park, So Jin Park, Woo Hyong Cho
American Journal of Analytical Chemistry (AJAC) , 2016, DOI: 10.4236/ajac.2016.711072
Abstract: A stability-indicating RP-HPLC method has been developed and validated for simultaneous determination of Valsartan & Hydrochlorothiazide and their impurities in FDC (Fixed Dose Combination) tablet dosage form. The method was developed using L1 column (250 × 4.6 mm; 5 μm) with gradient elution using the mobile phase consisting of solvent-A (0.1% Ortho phosphoric acid) and solvent-B (100% Acetonitrile); the gradient program (Tmin/%B) was set as 0/10, 5/10, 20/60, 40/60, 41/10 and 50/10. The eluted compounds were monitored at 265 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The influence of Acid, Alkaline, Oxidative, Photolytic, Thermal and Humidity stress conditions, on drug product was studied. The limit of quantification results of Valsartan, Hydrochlorothiazide and their impurities are, VAL: 0.303 μg/mL, HCTZ: 0.019 μg/mL, VAL RC-B: 0.085 μg/mL, VAL RC-C: 0.327 μg/mL, HCT RC-A: 0.017 μg/mL, CTZ: 0.080 μg/mL and 5-Chloro HCT: 0.047 μg/mL. The proposed method is suitable for the estimation of Valsartan & Hydrochlorothiazide impurities in tablets dosage form.
Simultaneous determination of valsartan and hydrochlorothiazide in tablets by RP-HPLC  [cached]
Tian D,Tian X,Tian T,Wang Z
Indian Journal of Pharmaceutical Sciences , 2008,
Abstract: A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for simultaneous determination of valsartan and hydrochlorothiazide in tablets. A column having 200 x 4.6 mm i.d. in isocratic mode with mobile phase containing methanol:acetonitrile:water:isopropylalcohol (22:18:68:2; adjusted to pH 8.0 using triethylamine; v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 270 nm. The retention time (min) and linearity range (μg/ml) for valsartan and hydrochlorothiazide were (3.42, 8.43) and (5-150, 78-234), respectively. The developed method was found to be accurate, precise and selective for simultaneous determination of valsartan and hydrochlorothiazide in tablets.
RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Forms  [cached]
Gaurav Patel,Sanjay Patel,Dharmesh Prajapati,Rajendra Mehta
Stamford Journal of Pharmaceutical Sciences , 2010,
Abstract: A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis.
RP-HPLC METHOD FOR SIMULTATANEOUS DETERMINATION OF AMLODIPINE BESYLATE, VALSARTAN, TELMISARTAN, HYDROCHLOROTHIAZIDE AND CHLORTHALIDONE: APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS
R. A. Mhaske et al.
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-hypertensive drugs Amlodipine Besylate, Valsartan, Telmisartan and diuretics Hydrochlorothiazide and Chlorthalidone. The separation was achieved on Cosmosil PAQ (150 mm × 4.6 mm) 5 μm column with gradient flow. The mobile phase at a flow rate of 1.0 mL min 1 consisted of 0.05 M sodium dihydrogen phosphate buffer and acetonitrile (Gradient ratio). The UV detection was carried out at 220 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.
Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma  [PDF]
Samya M. El-Gizawy, Osama H. Abdelmageed, Mahmoud A. Omar, Sayed M. Deryea, Ahmed M. Abdel-Megied
American Journal of Analytical Chemistry (AJAC) , 2012, DOI: 10.4236/ajac.2012.36055
Abstract: A simple, sensitive, and specific method was developed for simultaneous determination of Amlodipine besylate (AML), Valsartan (Vals) and Hydrochlorothiazide (HCT) by high performance liquid chromatography without previous separation. Satisfactory resolution was achieved using a RP-C18 chromatographic column, Phenomenex Kinetex (150 mm × 4.6 mm i.d) and a mobile phase consisting of acetonitrile-phosphate buffer (0.05 M) with pH 2.8 in the proportion of (40/60, v/v) at a flow rate 0.8 mL/min and the wavelength detection was 227 nm. The retention time for HCT, AML and VAls was 2.26, 3.16 and 11.19 min; respectively. The described method was linear over a range of 4-28 μg /ml, 5-40 μg /ml and 1-12 μg /ml for AML, Vals and HCT; respectively. The mean percent recoveries were 99.94%, 99.96% and 99.78% for AML, Vals and HCT; respectively. F-test and t-test at 95%con?dence level were used to check the intermediate precision data obtained under different experimental setups. The method could be used for analysis of combined dose tablet formulation containing AML, Vals, HCT as well as spiked human plasma.
Development and Validation of a RP-HPLC for the Simultaneous estimation of Atenolol and Hydrochlorothiazide in Pharmaceutical Dosage Forms
Zaveri Maitreyi,Amit Khandhar
International Journal of Advances in Pharmaceutical Sciences , 2011, DOI: 10.5138/165
Abstract: The reverse phase high performance liquid chromatography (RP-HPLC) method of Atenolol and Hydrochlorothiazide is individually available in United State of Pharmacopoeia-27 (USP-27) but no reference is available for combined estimation of Atenolol and Hydrochlorothiazide in tablets formulation. The aim of our present work was to develop a precise and validated RP-HPLC method for the simultaneous determination of Atenolol and Hydrochlorothiazide in tablets formulation. The quantification was carried out by using Zorbax SB-CN (250 x 4.6 mm), 5μm column in isocratic mode with mobile phase, Water: Buffer: Methanol (50:35:15). The flow rate was 1.2 ml/min. The peak purity of Atenolol and Hydrochlorothiazide were 0.999 and 1.000 respectively. Ruggedness and robustness of method were performed and the percentage relative standard deviation (RSD) was found below 2.0%. The percentage recovery was found in the range of 98% to 102% at three different levels. Calibration curves were linear over studies ranges with correlation co-efficient found between the range of 0.99 to 1.00. Sample and standard solution stability study was performed over 21 h at room temperature and found stable. The percentage deviation was below 2.0%. Keywords: Atenolol; Hydrochlorothiazide; RP-HPLC method; Combination Tablets.
Simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form by RP-HPLC method  [cached]
Patel L,Suhagia B,Shah P,Shah R
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form. A lichrospher 100 C-18, 5 μm column 20 cm x 4.6 mm in isocratic mode, with mobile phase containing water, acetonitrile and tetrahydrofuran in proportion of 80:20:5 v/v/v were used. The flow rate was 1 ml/min, and effluent was monitored at 225 nm. The retention time of bisoprolol fumarate and hydrochlorothiazide were 1.48 ± 0.02 and 4.72 ± 0.03 min respectively, and the resolution factor was 9.0. Linearity values for bisoprolol fumarate and hydrochlorothiazide were in the range of 10-150 μg/ml and 1-90 μg/ml respectively. The limit of detection and limit of quantification for bisoprolol fumarate was found to be 3.5 and 8.5 μg/ml respectively; and for hydrochlorothiazide, 0.4 and 0.9 μg/ml respectively. The proposed method is accurate, precise, specific and rapid for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form.
Simultaneous Estimation of Olmesartan medoxomil and Hydrochlorothiazide by RP-HPLC Method from Combined Dosage Forms
J. Ashok kumar,A. Sathya,K. Senthil kumar,Patil sagar. N
International Journal of Research in Pharmaceutical Sciences , 2010,
Abstract: A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was devel-oped for simultaneous estimation of olmesartan medoxomil (OLM) and hydrochlorothiazide (HCTZ) in combined tablet dosage form. Formulation containing OLM with HCTZ are used as antihypertensive angiotensin II receptor blocker. Chromatography was performed on a 250 mm x 4.6 mm, 5-μm particle size, C8 Qualisil BDS column with a 50:50 (v/v) mixture of buffer and acetonitrile as a mobile phase and the pH was adjusted to 4.7 by adding dilute phosphoric acid. The detection of the combined dosage form was carried out at 225 nm and a flow rate employed was 1 ml min-1. The retention times were 5.074 & 7.242 min for olmesartan medoxomil and hydrochlorothiazide, respectively. Linearity was obtained in the concentration range 20 to 100 μg mL-1 for olmesartan medoxomil and in the range 12.5 to 62.5 μg mL-1 for hydrochlorothiazide, with a correlation coefficient of 0.9956 and 0.989.The result of the analysis were validated statistically and recovery studies confirmed the accuracy and precision of the proposed method.
RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form  [cached]
Wankhede S,Tajne M,Gupta K,Wadodkar S
Indian Journal of Pharmaceutical Sciences , 2007,
Abstract: The present work describes a validated reverse phase high performance liquid chromatographic method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablet formulation. Chromatography was performed on a ODS Hypersil C18 (25 cmx4.6 mm I.D) column from thermo in isocratic mode with mobile phase containing acetonitrile:0.05 M KH2PO4 pH 3.0 (60:40). The flow rate was 1.0 ml/min and the eluent was monitored at 271 nm. The selected chromatographic conditions were found to effectively separate telmisartan (RT- 5.19 min) and hydrochlorothiazide (RT- 2.97 min). Linearity for telmisartan and hydrochlorothiazide were found in the range of 4.1-20.48 μg/ml and 1.28-6.4 μg/ml, respectively. The proposed method was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in tablet formulation.
HPTLC method for the simultaneous estimation of valsartan and hydrochlorothiazide in tablet dosage form  [cached]
Shah N,Suhagia B,Shah R,Patel N
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of valsartan and hydrochlorothiazide in combined dosage forms. The stationary phase used was precoated silica gel 60F 254 . The mobile phase used was a mixture of chloroform: methanol: toluene: glacial acetic acid (6:2:1:0.1 v/v/v/v). The detection of spots were carried out at 260 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 300 to 800 ng/spot for valsartan and 100 to 600 ng/spot for hydrochlorothiazide. The limit of detection and the limit of quantification for the valsartan were found to be 100 and 300 ng/spot respectively and for hydrochlorothiazide 30 and 100 ng/spot respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.
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