DEVELOPMENT OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ANALYSIS OF AMLODIPINE AND VALSARTAN IN COMBINED DOSAGE FORM AND IN VITRO DISSOLUTION STUDIED

Olga Yuryeva; Yuliya Kondratova; Liliya Logoyda

doi:10.22159/ajpcr.2018.v11i5.24443

Authors

Olga Yuryeva Central R&D Laboratory, JSC Farmak, Kyiv City, Ukraine
Yuliya Kondratova Central R&D Laboratory, JSC Farmak, Kyiv City, Ukraine
Liliya Logoyda Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil State Medical University, Ukraine.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i5.24443

Keywords:

Amlodipine besylate, Valsartan, High-performance liquid chromatography, Validation, Dissolution study

Abstract

Â Objective: A simple, rapid, and reproducible high-performance liquid chromatography method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms and for drug dissolution studies.

Methods: A C18 column (Zorbax Eclipse Ð¥DB-C18, 5 Î¼m, 2.1 mm Ã— 150 mm) and a mobile phase of water:acetonitrile:trifluoroacetic acid (55:45:0.1 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow rate of 0.4 mL/min and at ambient temperature. The injection volume was 5 Î¼L and the ultraviolet detector was set at 265 nm. The method was validated as per ICH guidelines.

Results: Under these conditions, amlodipine and valsartan were eluted at 1.64 min and 4.08 min, respectively. Total run time was shorter than 7 min. The results were 99.6 Â± 0.6 and 98.5 Â± 0.8 for amlodipine and valsartan, respectively. Valsartan was released within 15 min (98.32%) and amlodipine was also released within 30 min (96.16%) both at a pH of 6.8.

Conclusion: The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.

Downloads

Download data is not yet available.

References

Chitlange SS, Bagri K, Sakarkar DM. Stability indicating RP-HPLC method for simultaneous estimation of valsartan and amlodipine in capsule formulation. Asian J Res Chem 2008;28:15-8.

Kondratova Y, Adebayo T, Logoyda L, Korobko D, Berdey I, Kuchmerovska T. Development of the methodology of the chromatographic determination of amlodipine in medicines. Int J Res Ayurveda Pharm 2016;7:32-5.

Celebier M, Kaynak MS, Altinoz S, Sahin S. Validated HPLC method development: The simultaneous analysis of amlodipine and valsartan in samples for liver perfusion studies. Hacettepe Univ J Fac Pharm 2008;28:15-30.

Naidu KR, Kale UN, Shingare MS. Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product. J Pharm Biomed Anal 2005;39:147-55.

Ravi SS, Nanjan MJ, Vasudevan M, Shaat N, Suresh B, Sankar SR. Simultaneous estimation of atenolol and amlodipine in formulation by RP-HPLC. Indian J Pharma Sci 1997;59:171-3.

Meyyanathan SN, Suresh B. HPTLC method for the simultaneous determination of amlodipine and benazepril in their formulations. J Chromatogr Sci 2005;43:73-5.

Polyauk O, Logoyda L. The investigation of conditions of API from group of calcium channel blockers extraction by organic solvents by using high-performance liquid chromatography as assay method. Asian J Pharm Clin Res 2017;10:354-6.

Logoyda L, Korobko D, Samohalska O, Berdey I. Development of methodology for identification of captopril in medicines. Asian J Pharm 2016;10:168-71.

Kondratova Y, Logoyda L, Voloshko Y, Abdel-Megied A, Korobko D, Soroka Y. Development and validation of HPLC-DAD method for the determination of bisoprolol in tablet dosage forms. Int J Appl Pharm 2017;9:54-9.

ICH Q2 (R1), Validation of Analytical Procedures. Text and Methodology. Geneva: International Conference on Harmonization; 2005. p. 1-17.