<abstract xml:lang="en" xmlns="http://www.w3.org/1999/xhtml">A simple RP-HPLC method for the quantification of valsartan (VAL), amlodipine (AML) and hydrochlorothiazide (HCT) in human plasma was developed and validated. VAL, AML and HCT were resolved using a Gemini C18 column and mobile phase gradient starting from 20 % acetonitrile and 80 % 10 mmol L-1 ammonium formate (V/V, pH 3.5 ± 0.2, by formic acid) to 70 % acetonitrile and 30 % 10 mmol L-1 ammonium formate, over 20 minutes, with a flow rate of 1 mL min-1. The samples were purified by protein precipitation and extraction. Telmisartan was used as internal standard. The method was validated according to USFDA and EMEA guidelines with good reproducibility and linear responses <italic>R</italic> = 0.9985 (VAL), 0.9964 (AML), and 0.9971 (HCT). RSDs of intra- and inter-day precision ranged 2.2-8.1 and 4.6-11.7 %, respectively, for all three drugs. Mean extraction recoveries of three QCs for the triple drug combination were 76.5 (VAL), 72.0 (AML) and 73.0 (HCT) % for human plasma. Although the LC-MS/MS method is more sensitive than HPLC, HPLC is still suitable for preliminary pharmacokinetic study. The experiments performed demostrated that simultaneous determination of all components of the triple drug combination in human plasma can be done by this method. Proposed method can be also used for guidance to the LC-MS/MS method.</abstract>

A simple RP-HPLC method for the quantification of valsartan (VAL), amlodipine (AML) and hydrochlorothiazide (HCT) in human plasma was developed and validated. VAL, AML and HCT were resolved using a Gemini C18 column and mobile phase gradient starting from 20 % acetonitrile and 80 % 10 mmol L-1 ammonium formate (V/V, pH 3.5 ± 0.2, by formic acid) to 70 % acetonitrile and 30 % 10 mmol L-1 ammonium formate, over 20 minutes, with a flow rate of 1 mL min-1. The samples were purified by protein precipitation and extraction. Telmisartan was used as internal standard. The method was validated according to USFDA and EMEA guidelines with good reproducibility and linear responses R = 0.9985 (VAL), 0.9964 (AML), and 0.9971 (HCT). RSDs of intra- and inter-day precision ranged 2.2-8.1 and 4.6-11.7 %, respectively, for all three drugs. Mean extraction recoveries of three QCs for the triple drug combination were 76.5 (VAL), 72.0 (AML) and 73.0 (HCT) % for human plasma. Although the LC-MS/MS method is more sensitive than HPLC, HPLC is still suitable for preliminary pharmacokinetic study. The experiments performed demostrated that simultaneous determination of all components of the triple drug combination in human plasma can be done by this method. Proposed method can be also used for guidance to the LC-MS/MS method.

Simple RP-HPLC method for determination of triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma

S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mahesana-Gozaria Highway Kherva Dist. Mahesana-382711, Gujarat, India

Babria Institute of Pharmacy, Varnama, Vadodara-391240, Gujarat, India

Acta Pharmaceutica

A simple RP-HPLC method for the quantification of valsartan (VAL), amlodipine (AML) and hydrochlorothiazide (HCT) in human plasma was developed and validated....

Simple RP-HPLC method for determination of triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma

Published Online: Apr 03, 2012

Page range: 45 - 58

DOI: https://doi.org/10.2478/v10007-012-0004-3

Keywords
valsartan, amlodipin, hidroklorotiazid, RP-HPLC, taloženje proteina, kombinacija tri lijeka

This content is open access.

Simple RP-HPLC method for determination of triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma

Published Online: Apr 03, 2012

Page range: 45 - 58

DOI: https://doi.org/10.2478/v10007-012-0004-3

Keywordsvalsartan, amlodipin, hidroklorotiazid, RP-HPLC, taloženje proteina, kombinacija tri lijeka

This content is open access.

Keywords
valsartan, amlodipin, hidroklorotiazid, RP-HPLC, taloženje proteina, kombinacija tri lijeka