DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ALISKIREN HEMIFUMARATE AND VALSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM
Abstract
Objective: A new, simple, selective, and reproducible stability indicating reversed - phase high performance liquid chromatography method for the
simultaneous estimation of Aliskiren (ALN) Hemifumarate and Valsartan (VLN) in bulk drug, and tablet dosage form was developed and validated as
per ICH guidelines.
Methods: The chromatographic separation was performed using a nucleosil C - 18 column and the analytes were detected by a malondialdehyde - 2010
photodiode array detector. The mobile phase composed of methanol: potassium dihydrogen ortho phosphate buffer (adjusted to pH 3 with
orthophosphoric acid). The flow rate was set at 1 ml/minutes, and the detection was carried out at 225 nm.
Results: ALN Hemifumarate and VLN showed a retention time of 3.84 and 5.96 minutes, respectively. The linear dynamic range was found to be
5-50 mcg/ml and 5-30 mcg/ml with a co-relation co-efficient of 0.992 and 0.985 for ALN and VLN, respectively, with mean percentage recoveries of
99.95% and 99.25%. The results were validated and were found to successfully obey the parameters as per ICH guidelines.
Conclusion: Hence, the method can be successfully applied for routine quality control analysis and stability studies for both ALN Hemifumarate and
VLN in bulk and tablet dosage form as per regulatory requirements.
Keywords: Aliskiren Hemifumarate, Valsartan, Reversed-phase high performance liquid chromatography, Stress degradation study, ICH guidelines.
Downloads
References
FDA guidance for industry , Analytical procedures and methods
validation for drugs and biological , U.S. Department of Health and
Human Services Food and Drug Administration , Protocol for stability
Testing August 2000 , Pg 5.
The Merck Index, Monographs no. 3521, 3535. Merck and Co, 14th
edition 2006.Merck Sharp & Dohme Corp., Whitehouse Station, N.J.,
U.S.A.
Dieterich H, Kemp C, Vaidyanathan S, and Yeh C, Aliskiren, the first
in a new class of orally effective rennin inhibitors, has no clinically
significant drug interactions with Digoxin in healthy volunteers.
Clinical Pharmacology & Therapeutics 2006, 79(2):P64.
British Pharmacopoeia, Govt. British Pharmacopieal, commission
Published by The Stationery Office on behalf of the Medicines and
Healthcare products Regulatory Agency (MHRA), 2011, Volume I
and II, Monograph 2423. London, United Kingdom.
Aydogmu Z, San F. Spectrofluorimetric determination of aliskiren in
tablets and spiked human plasma through derivatization technique
using dansyl chloride. J Fluoresc 2012;22:549-56.
Parmar K, Shah J. Simultaneous estimation of aliskiren and valsartan
by ratio spectra derivative spectrophotometry method in their fixed
dosage forms. Int J ChemTech Res 2014;6(2):1268-75.
Pachauri S. 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.
Rekulapally VK. 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
;6(1):724-30.
Ghosh S, Anusha B, Santoshi. Method development and validation
of aliskiren hemifumarate and valsartan in bulk drug by RP-HPLC
method. Asian J Res Chem 2013;06(01):19.
Chokshi PV, Trivedi KJ. Development and validation of RP-HPLC
method for simultaneous estimation of aliskiren hemifumarate and
valsartan in their combination tablet dosage form. Int J ChemTech Res
;4(4):1623-7.
Kumaraswamy G, Sheshairi Rao JV. Validated RP-HPLC method for
simultaneous estimation of aliskiren and valsartan in tablet dosage
Form. J Drug Deliv Therap 2012;2(5):162-6.
International Conference on Harmonization (ICH), ICH Harmonised
Tripartite Guideline for Stability Testing - Q1B.
International Conference on Harmonization (ICH), Validation of
Analytical Procedures: Methodology Q2B, 1996.
ICH, Q1A (R2): Stability testing of new drug substances and products,
ICH Harmonized Tripartite Guideline. Geneva, Switzerland; 2003.
ICH. Q1B: Stability Testing: Photo stability Testing of New Drug
Substances and Products, ICH Harmonized Tripartite Guideline.
Geneva, Switzerland; 2003.
ICH Q2 (R1): Validation of Analytical Procedures: Text and
Methodology, ICH Harmonized Tripartite Guideline. Geneva,
Switzerland; 2003.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.