QUANTITATIVE SIMULTANEOUS DETERMINATION OF ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE IN COMBINED TABLET FORMULATION BY RP-HPLC
Keywords:
Aliskiren hemifumarate, Hydrochlorothiazide, RP-HPLC, Tablet formulationAbstract
Objective: Development and validation of quantitative simultaneous determination of aliskiren hemifumarate (ALI) and hydrochlorothiazide (HCT) in combined tablet formulation by RP-HPLC.
Methods: The separation of components were achieved on Enable C18 column (250×4.6 mm, 5 µm) with a mobile phase consisting of 0.2 %v/v triethylamine in water (pH 6 was adjusted with orthophosphoric acid): methanol (10:90 %v/v) at a flow rate of 1 ml/min was employed. Quantification was achieved with PDA detection at 280 nm. Validation parameters of the proposed method such as specificity, linearity, accuracy, precision and robustness were evaluated according to ICH guidelines.
Results: Linear concentration range was between 1.2-240 µg/ml for ALI and 0.1-20 µg/ml for HCT and correlation coefficient was found to be 0.9995 and 0.9998, respectively. The limit of detection and limit of quantification for ALI was found to be 0.3376 and 1.0230 µg/ml and for HCT 0.0288 and 0.0873 µg/ml, respectively. The results of precision (% RSD<2) studies showed good reproducibility. Recovery study was performed at 50, 100 and 150 % level to check the interferences between analytes and formulation excipients and % recovery was found to be 99.49±0.9868 for ALI and 99.87±0.8556 for HCT. The percentage assay was found to be 100.36±0.9201 and 99.40±0.7624 for ALI and HCT, respectively.
Conclusion: A simple, rapid, cost effective and highly sensitive RP-HPLC method as compared to existing methods for the determination of ALI and HCT in tablet formulation was developed and validated as per ICH guidelines. The method uses simple reagents and sample preparation procedures were minimal. Thus, the proposed method can be applied for routine quality control determination of ALI and HCT in tablet formulation.
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References
Martindale, The complete drug reference. 36th edition. Vol. I. London (UK): Pharmaceutical Press (An Imprint of RPS Publishing); 2009.
The Merck Index, An encyclopedia of chemicals, drug and biological. 13th edition. White House Station (NJ), Merck & Co Inc; 2001.
Sangoi MS, Sangoi MW, Oliveira PR, Todeschini V, Rolim CMB. Rapid simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical formulations by monolithic silica HPLC column employing experimental designs. J Liq Chromatogr Relat Technol 2011;34(17):1976-96.
Sangoi MW, Sangoi MS, Oliveira PR, Secretti LT, Rolim CMB. Determination of aliskiren in tablet dosage forms by a validated stability indicating RP-LC method. J Chromatogr Sci 2011;49(2):170-5.
Ashok S, Varma MS, Swaminathan S. A validated LC method for the determination of the enantiometric purity of aliskiren hemifumarate in bulk drug samples. J Chromatogr Sci 2012;50(9):799-802.
Dimitrios K, Eleni K, Irene P. A stability indicating HPLC method for the quantification of aliskiren and hydrochlorothiazide in a pharmaceutical formulation. J AOAC Int 2014;97(6):1519-25.
Swamy GK, Sravanthi P, Surekha ML, Kumar JMR, Rao JVLNS. Validated RP-HPLC method for the simultaneous determination of aliskiren, hydrochlorothiazide and amlodipine besylate in bulk and pharmaceutical formulations. Int J Chem Tech Res 2012;4(4):1666-73.
Swamy GK, Rao JVLNS, Kumar JMR, Kumar UA, Bikshapathi DVRN, Kumar DV. Analytical method development and validation of aliskiren in bulk and tablet dosage form by RP-HPLC method. J Pharm Res 2011;4(3):865-7.
Babu SK, Rao JVLNS, Bhargava VK. A simple and sensitive method for the determination of aliskiren hemifumarate using HPLC-UV detection. Rasayan J Chem 2011;4(2):285-8.
Ezzeldin MI, Shokry E, Fouad MA, Elbagary RI. Application of chromatographic and spectrophotometric methods for the analysis of selected antihypertensive combination. Int J Anal Pharm Biomed Sci 2013;2(3):6-15.
Ezzeldin MI, Shokry E, Fouad MA, Elbagary RI. Application of chromatographic and spectrophotometric methods for the analysis of aliskiren and hydrochlorothiazide antihypertensive combination. Int J Adv Chem 2013;1(2):13-20.
Pachauri S, Paliwal S, Srinivas KS, Singh Y, Jain V. Development & validation of HPLC method for analysis of some antihypertensive agents in their pharmaceutical dosage forms. J Pharm Sci Res 2010;2(8):459-64.
Renukapally VK, Rao VU. Stability indicating RP-HPLC method development and validation for simultaneous estimation of aliskiren, amlodipine and hydrochlorothiazide in tablet dosage form. Int J Pharm Pharm Sci 2014;6(1):724-30.
Alagar RM, Ragavendra P, Banji D, Rao KNV, Chaithanya Y, Selvakumar D. RP-HPLC method for simultaneous estimation of aliskiren hemifumarate, hydrochlorothiazide and amlodipine in pharmaceutical bulk drugs and tablet dosage form. J Pharm Res 2012;5(8):4580-5.
Prathyusha W, Tengli AR, Chandan RS, Gurupadayya BM, Sai TV. Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide in bulk and pharmaceutical dosage forms. IOSR J Pharm Biol Sci 2014;9(1):114-23.
Kadukar SS, Gandhi SV, Ranjane PN, Ranher SS. HPTLC analysis of olmesartan medoxomil and hydrochlorothiazide in combination tablet dosage forms. J Planar Chromatogr Mod TLC 2009;22(6):425-8.
Bari PD, Rote AR. RP-LC and HPTLC methods for the determination of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage forms. Chromatographia 2009;69(11-12):1469-72.
Shah NJ, Suhagia BN, Shah RR, Patel NM. Development and validation of a simultaneous hptlc method for the estimation of olmesartan medoxomil and hydrochlorothiazide in tablet dosage form. Indian J Pharm Sci 2007;69(6):834-6.
Parmar K, Shah J. Simultaneous estimation of aliskiren and valsartan by ratio spectra derivative spectrophotometry method in their fixed dosage forms. Int J Chem Tech Res 2014;6(2):1268-75.
Salim MM, Ebeid WM, El-Enany N, Belal F, Walash M, Patonay G. Simultaneous determination of aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis. J Sep Sci 2014;37(9-10):1206-13.
International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva; 2005.