Bioanalytical HPLC method development for simultaneous determination of valsartan and co-administered clopidogrel bisulfate and fenofibrate in stroke prevention in raw materials, spiked human plasma and tablets

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This study reports about simple, robust and reproducible method for simultaneous bioanalytical determination of Valsartan (VAL) and co-administered Clopidogrel bisulfate (CGB) and Fenofibrate (FEN) in raw materials, spiked human plasma and tablets using isocratic RP-HPLC method. The chromatographic separation is carried out using isocratic binary mobile phase consisting of 80 mM phosphate buffer pH 3: Acetonitrile (30: 70 %; v/v) at the flow rate of 1.1 mL/min and 33 °C. A Diode array detector at wavelength 214 nm was used. Retention times for VAL, CGB and FEN were 3.1, 5.1 and 6.4 min, respectively. The calibration curves obtained were linear over the concentration ranges of 2.5 - 100 μg/mL for both VAL and CGB and 5 -100 μg/mL for FEN. The mean extraction recoveries of VAL, CGB and FEN from spiked plasma were 75.38±1.34 %, 89.91±2.17 % and 96.92±6.02 %, respectively. The limits of detection and quantification were 0.86, 0.67, 1.11 μg/mL and 2.60, 2.03, 3.36 μg/mL for VAL, CGB and FEN, respectively. The method was applied to the analysis of these drugs in spiked human plasma and in tablets as they are commonly used as a combination for prevention of stroke. Results obtained show good accuracy, precision and acceptable recoveries from plasma samples.

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  • El-Gizawy SM Abdelmageed OH Omar MA Duryea SM Abdel-Megied AM (2012) Development and validation of HPLC method for simultaneous determination of amlodipine valsartan hydrochlorothiazide in dosage form and spiked human plasma. Am. J. Analyt. Chem. 3: 422-430.

  • Gupta KR Wadodkar AR. Wadodkar SG (2010a) UVSpectrophotometric methods for estimation of valsartan in bulk and tablet dosage form. Int. J. Chemtech. Res. 2: 985-989.

  • Gupta KR Askarkar SS Rathod PR Wadodkar SG (2010b) Validated spectrophotometric determination of Fenofibrate in formulation. Pharm. Sin. 1: 173-178.

  • Gurupadayya BM Sam S (2014) Bio-analytical determination of Clopidogrel bisulfate and pantoprazole by RP-HPlC method in rat plasma: Application to drug interaction study. Asian J. Pharm. Clin. Res. 7: 10-13.

  • Gu Q Burt VL Dillon CF Yoon S. (2012) Trends in antihypertensive medication use and blood pressure control among United States adults with hypertension: the National Health and Nutrition Examination Survey 2001 to 2010. Circulation 126: 2105-2114.

  • Hall MJ Levant S Defrances CJ (2012) Hospitalization for stroke in US hospitals 1989-2009. NCHS Data Brief 95: 1-8.

  • International Conference On Harmonization. Validation of Analytical Procedures: Text and Methodology 2005. Jain N Raghuwanshi R Jain D (2008) Development and Validation of RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. Indian J. Pharm. Sci. 70: 263-265.

  • Khaleel N Abdul Rahaman SK (2016) Validated stability indicating RP-HPLC method for simultaneous determination of atorvastatin Fenofibrate and folic acid in bulk and pharmaceutical dosage form. Pharm. Lett. 8: 13-32.

  • Kernan WN Ovbiagele B Black HR (2014) Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 45: 2160-2236.

  • Lackland DT Roccella EJ Deutsch AF (2014) Factors influencing the decline in stroke mortality: a statement from the American Heart Association/American Stroke Association. Stroke 45: 315-353.

  • Londhe SV Deshmukh RS Mulgund SV Jain KS (2011) Development and validation of a Reversed-phase HPLC method for simultaneous determination of aspirin atorvastatin calcium and Clopidogrel bisulfate in capsules. Indian J. Pharm. Sci. 73: 23-29.

  • Ovbiagele B (2011) National sex-specific trends in hospitalbased stroke rates. J. Stroke Cerebrovascular Dis. 20: 537-540.

  • Rosengren A Giang KW Lappas G Jern C Toren K Bjorck L (2013) Twenty-four-year trends in the incidence of ischemic stroke in Sweden from 1987 to 2010. Stroke 44: 2388-2393.

  • Sahu PK Murthy Pyla SR Srinivas K Swain S (2016) Simultaneous RP-HPLC method development and validation of atorvastatin ezetimibe and fenofibrate. Pharmaceut. Reg. Affairs 5: 1-6.

  • Shrivastava PK Basniwal PK Jain D Shrivastava SK (2008) Concurrent estimation of Clopidogrel bisulfate and aspirin in tablets by validated RP-HPLC method. Indian J. Pharm. Sci. 70: 667-669.

  • Sweetman S (2009) Martindale The complete drug reference 36th edition Pharmaceutical Press cop. London UK 3694 p.

  • Tian DF Tian XL Tian T Wang ZY Mo FK (2008) Simultaneous determination of valsartan and hydrochlorothiazide in tablets by RP-HPLC. Indian J. Pharm. Sci. 70: 372-374.

  • The British Pharmacopoeia. London UK Her Majesty’s Stationary Office 2017.

  • The United States Pharmacopoeia Vol. XXIV Washington 2007.

  • Wang Y Rudd AG Wolfe CD (2013) Trends and survival between ethnic groups after stroke: the South London Stroke Register. Stroke 44: 380-387.

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