SEPARATION AND ANALYSIS OF AMLODIPINE/BENAZEPRIL COMBINATION IN CAPSULES BY A NOVEL ION PAIR LIQUID CHROMATOGRAPHY
Objective: The objective of this study was to develop and validate a novel ion-pair liquid chromatography method, in order to separate and assay of amlodipine/benazepril combination in capsules. This method was a fast, practical and additional choice in quality control laboratories.
Methods: The chromatographic conditions comprised of a classical C18-type stationary phase (250 × 4.6 mm, 5μ), with a mobile phase consisting of: 45% of 10-3 M of cetrimide and 55% acetonitrile. The flow rate was 1 ml/min; the detection wavelength was at 242 nm, under ambient temperature.
Results: The method was validated for linearity with correlation coefficients very close to one, the accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products and excipients.
Conclusion: The results presented in this paper showed that the developed method was fast and applicable, for the separation and determination of amlodipine/benazepril combination in capsules.
2. British Pharmacopeia Online; 2015.
3. Abhi K, Manju M. Development and validation of RP-HPLC and UV-spectrophotometric methods for rapid simultaneous estimation of amlodipine and benazepril in pure and fixed dose combination. Arab J Chem 2017;10:s3021-28.
4. Hemdan A, Omar AE, Farouk M, Shereen MT, Mostafa AS. Development of validated stability indicating RP-HPLC method for simultaneous determination of benazepril, benaziprilate, and amlodipine in the presence of their degradation products and application to the pharmaceutical formulation and human plasma. Colloids Surf B 2016;16:112.
5. Ashour S, Alhaj Sakur A, Kudemati MA. Validated stability is indicating a liquid chromatographic method for the simultaneous determination of amlodipine and benazepril in capsules dosage form. Canadian Chem Trans 2014;2:418-33.
6. Rama JVE, Gopichant I, Venkatasubramanian J, Raghuram P, Sudhakar RV, Jadi SR. New stability indicating for quantification of impurities in amlodipine and benazepril capsules by validated HPLC. Am J Anal Chem 2013;4:715-24.
7. Sarat M, Murali Krishna P, Rambabu C. Development and validation of RPHPLC method for simultaneous estimation of amlodipine besylate and benazepril HCl in the tablet dosage form. Int J Curr Pharm Res 2012;4:80-4.
8. Gajanan BK, Mazahar NF. Simultaneous determination of amlodipine and benazepril hydrochloride in pharmaceutical dosage form by LC. Anal Sci 2009;25:1495-8.
9. 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.
10. Osman RAM, Elbashir AA. A high-performance liquid HPLC method for simultaneous the determination of amlodipine drug in dosage form using1,2-naphthoquine-4-sulfonate. J Anal Pharm Res 2017;6:163-70.
11. Chitlange SS, Imran M, Sakarkar DM. RP-HPLC method for simultaneous estimation of amlodipine and metoprolol in tablet formulation. Asian J Pharm 2008;4:232-4.
12. Celebier M, Kaynak MS, Altinoz S, Sahin S. HPLC method for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies. Braz J Pharm Sci 2010;46:761-8.
13. Hafez HM, Elshanawany AA, Abdelaziz LM, Mohram MS. Development of a stability-indicating HPLC method for simultaneous determination of amlodipine besylate and atorvastatin calcium in bulk and pharmaceutical dosage form. Pharm Anal Acta 2014;5:316-5.
14. Chhalotiya UK, Varsha LP, Dimal AS, Kashyap KB, Sunil LB. Stability-indicating LC method for the estimation of benazepril HCl and hydrochlorothiazide in the pharmaceutical dosage form. J Chrom Sep Tech 2014;5:216-22.
15. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 10 Aug 2018].
16. Taverniers I, De loose M, Van Bockstaele E. Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance. Trends Anal Chem 2004;23:535-52.
17. Taverniers I, Van Bockstaele E, De loose M. Trends in quality in the analytical laboratory. I. traceability and measurement uncertainty of analytical results. Trends Anal Chem 2004;23:480-90.
18. Ermer J, Miller JH Mc. Method validation in pharmaceutical analysis. WILEY-VCH Verlag GmbH and Co. KGa A, Weinheim; 2005.
19. United Stated Pharmacopoeia USP 38/National Formulary NF 33; 2015.