DEVELOPMENT OF ULTRA-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF CAPTOPRIL IN PHARMACEUTICAL DOSAGE FORMS
Keywords:Captopril, Hydrochlorothiazide, Ultra-high-performance liquid chromatography, Pharmaceutical dosage forms
Objective: The objective of this research was to develop more simple, sensitive, accurate, and less expensive analytical methods for the determination of captopril in medicines by Ultra-high-performance liquid chromatography.
Materials and Methods: The chromatographic analysis of captopril performed on liquid chromatography Agilent 1290 Infinity II LC System.
Results: A simple, rapid, sensitive, and specific method was developed for the determination of captopril by ultra-high-performance liquid chromatography in mono-medicines and pharmaceutical dosage forms in combination with hydrochlorothiazide without previous separation. Satisfactory resolution was achieved using Fused-CoreÂ® technology Ascentis Express C18 column (4.6Ã—150 mm) and a mobile phase consisting of methanol and 0.1% solution of trifluoroacetic acid (40/60, v/v) at a flow rate 1.2 mL/minute and the wavelength detection was 220 nm. Ascentis Express columns, based on FusÐµd-core pÐ°rticle technÐ¾logy, prÐ¾vide more than twice the speed and efficiency of traditiÐ¾nal cÐ¾lumns at half the backpressure of sub-2-Î¼m columns. The retention time for captopril was 1.345 minute. The validation of this method was based on the ICH and USP guidelines.
Conclusion: The results obtained in this research work clearly indicated that the assay was rapid, sensitive and successfully applied to the determination of both drugs in pharmaceutical dosage forms without interference from tablet excipients.
United States Pharmacopoeia (USP). Medicare Prescription Drug Benefit Model Guidelines Source Information. Available from: http://www.nlm.nih.gov.
State Pharmacopoeia of Ukraine, State Enterprise. State Enterprise, Ukrainian Scientific Center Pharmacopoeia Quality Medicines. 2nd ed., Vol. 3. Kharkiv: State Pharmacopoeia of Ukraine, State Enterprise; 2014. p. 724.
State Pharmacopoeia of Ukraine, State Enterprise. Scientific and Expert Centre pharmacopoeia, Appendix 2. 1st ed. Kharkiv: State Enterprise, Ukrainian Scientific Center of Quality Pharmacopoeia of Medicines; 2008. p. 620.
Logoyda L. Development and validation of new methods of analysis for the determination of different natural and synthetic original active pharmaceutical ingredients in medicines. Duphat 2015;48:6.
Logoyda L, Korobko D, Ivanusa I, Serhii K. Development of the methodology of the chromatographic determination of nifedipine in medicines. Asian J Pharm Clin Res 2017;10(3):149-52.
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(4):32-5.
Saifi M, Ali A, Saini M, Nasrullah N, Khan S, Abdin MZ. A rapid and efficient high-performance thin-layer chromatographic (HPTLC) method for simultaneous analysis of stevioside and rebaudioside-a in Stevia rebaudiana. Int J Pharm Pharm Sci 2014;6:455-64.
Sharma T, Moitra SK, Si SC, Sankar DG. Development and validation of a HPLC method for the determination of valsartan and its degradation products in a pharmaceutical formulation. Int J Pharm Pharm Sci 2012;4:299-303.
Khaja P, Asgar A, Shanana B, Syed AH. Reverse phase-HPLC method for the analysis of tinidazole in the pharmaceutical dosage form and bulk drug. Int J Pharm Pharm Sci 2010;2:46-7.
Raul SK, Aravelli AB, Jhansi D. RP-HPLC method development and validation for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage form. Asian J Pharm Clin Res 2015;8:178-81.
ICH. Harmonized Tripartite Guidelines on Validation of Analytical procedures: Text and Methodology Q2 (R1). Current Step 4 Version. Geneva: ICH; 2005.
Logoyda L. Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines. Egypt: Pharma School Association for Pharmaceutical Development and Scientific Research; 2016. p. 34.
How to Cite
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.