Development and Validation of Analytical Methods for Simultaneous Estimation of Lercanidipine Hydrochloride and Enalapril Maleate
Pharmaceutical Science-Pharmaceutical Analysis
DOI:
https://doi.org/10.22376/ijlpr.2023.13.2.P99-P112Keywords:
Lercanidipine Hydrochloride, Enalapril maleate, Simultaneous Equation Method, First Order Derivative Method, ChemometricsAbstract
The fixed dose of lercanidipine hydrochloride(LH) and enalapril maleate (EM) is used to provide more effective control of hypertension. The research work was aimed at the development and validation of simple and sensitive analytical methods for their quantification from tablets. The simultaneous equation, first-order derivative, and multivariate spectrophotometric methods were developed for the simultaneous estimation of LH and EM in tablets. The simultaneous equation method involves a determination of LH and EM at 236 nm and 207 nm, respectively. First order derivative UV spectrophotometry method involves using a zero crossing point of LH at 330 nm and EM at 219 nm. Both methods were validated as per ICH Q2 (R2) guidelines and found to be accurate and precise as they exhibited <2% relative standard deviation. The limit of detection (LOD) and limit of quantitation (LOQ) for LH were found to be 0.26 μg/ml and 0.78 μg/ml respectively whereas LOD and LOQ for EM were found to be 0.41 μg/ml and 1.24 μg/ml respectively for simultaneous equation method. The LOD and LOQ for LH were found to be 0.39 μg/ml and 1.19 μg/ml respectively whereas LOD and LOQ for EM were found to be 0.31 μg/ml and 0.97μg/ml respectively for the first-order derivative method. Three Chemometric methods namely classical least square (CLS), principal component regression (PCR), and partial least square (PLS) were studied for the simultaneous determination of LH and EM in tablets using spectrophotometry. A set of 25 standard mixtures containing both drugs were prepared in the range of 5–25 μg/ml for both drugs. The analytical figure of merit (FOM) was determined for all three chemometric methods. The LOD values for LH were found to be 0.97, 0.93, and 0.94 μg/ml and 0.90,0.88, and 0.89 μg/ml for EM using CLS, PCR, and PLS modeling techniques. The proposed methods were user-friendly, rapid, and sensitive enough for the determination of LH and EM.
References
Grassi G, Robles NR, Seravalle G, Fici F. Lercanidipine in the management of hypertension: an update. J Pharmacol Pharmacother. 2017 Oct-Dec;8(4):155-65. doi: 10.4103/jpp.JPP_34_17, PMID 29472747, PMCID PMC5820745.
Shaikh FI, Patel VB. Enhancement of dissolution of lercanidipine hydrochloride using solid dispersion technique. Res J Recent Sci. 2015;4:299-307.
Ha ES, Choo GH, Baek IH, Kim JS, Cho W, Jung YS et al. Dissolution and bioavailability of lercanidipine-hydroxypropylmethyl cellulose nanoparticles with surfactant. Int J Biol Macromol. 2015 Jan;72:218-22. doi: 10.1016/j.ijbiomac.2014.08.017. PMID 25159878.
Gopal PN, Hemakumar A, Padma SVN. HPLC Method for estimation of lercanidipine in pharmaceutical dosage forms. Asian J Chem. 2008;20:530-4.
Mubeen G, Mamta P, Vimala MN. HPLC method for analysis of lercanidipine hydrochloride in tablets. Int J Pharm Biol Sci. 2010;1:1-5.
Alvarez-Lueje A, Pujol S, Squella JA, Núñez-Vergara LJ. A selective HPLC method for determination of lercanidipine in tablets. J Pharm Biomed Anal. 2003 Feb 5;31(1):1-9. doi: 10.1016/s0731-7085(02)00601-5, PMID 12560043.
Mihaljica S, Radulovi? D, Trbojevi? J. Determination of lercanidipine hydrochloride and its impurities in tablets. Chromatographia. 2005;61(1-2):25-9. doi: 10.1365/s10337-004-0465-8.
Chonkar AD, Managuli RS, Rao JV, Udupa N. Development and validation of reversed phase high-performance liquid chromatography method for estimation of lercanidipine HCl in pure form and from nanosuspension formulation. J Basic Clin Pharm. 2015 Dec;7(1):17-22. doi: 10.4103/0976-0105.170586, PMID 26792958, PMCID PMC4702276.
Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK. A stability-indicating HPLC method for assay of lercanidipine hydrochloride in tablets and for determining content uniformity. Indian J Pharm Sci. 2010 May;72(3):381-4. doi: 10.4103/0250-474X.70490, PMID 21188053, PMCID PMC3003177.
Mohan M, Haider SZ, Anand AK, Srivastva AK. Validation of stability indicating HPLC method for the determination of enalapril maleate in tablet formulations. Int J Pharm Pharm Sci. 2010;3:180-83.
Thongnopnua P, Poeaknapo C. High-performance liquid chromatographic determination of enalapril in human plasma by enzyme kinetic analytical method. J Pharm Biomed Anal. 2005 Apr 1;37(4):763-9. doi: 10.1016/j.jpba.2004.10.053. PMID 15797799.
Trabelsi H, Bouabdallah S, Sabbah S, Raouafi F, Bouzouita K. Study of the cis–trans isomerization of enalapril by reversed-phase liquid chromatography. J Chromatogr A. 2000 Feb 25;871(1-2):189-99. doi: 10.1016/s0021-9673(99)01214-5, PMID 10735299.
Stanisz B. Evaluation of stability of enalapril maleate in solid phase. J Pharm Biomed Anal. 2003 Feb 26;31(2):375-80. doi: 10.1016/s0731-7085(02)00325-4, PMID 12609677.
Diego Md, Godoy G, Mennickent S, Godoy R. Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method. Quim Nova. 2011;34(3):450-54. doi: 10.1590/S0100-40422011000300016.
El Walily AF, Belal SF, Heaba EA, el Kersh A. Simultaneous determination of enalapril maleate and hydrochlorothiazide by first-derivative ultraviolet spectrophotometry and high-performance liquid chromatography. J Pharm Biomed Anal. 1995 Jun;13(7):851-6. doi: 10.1016/0731-7085(95)01346-m, PMID 8562608.
Shah PN, Patel BN, Patel CN, Dave JB. RP-HPLC Method of simultaneous estimation of enalapril maleate and lercanidipine HCl in synthetic mixture. Int J Res Pharm Chem. 2011;1:308-14.
Gumustas M, Sanlı S, Sanli N, Ozkan SA. Determination of pK(a) values of some antihypertensive drugs by liquid chromatography and simultaneous assay of lercanidipine and enalapril in their binary mixtures. Talanta. 2010 Sep 15;82(4):1528-37. doi: 10.1016/j.talanta.2010.07.037. PMID 20801368.
Lodha RS, Shah AS, Shah RD, Shah DR, Kalyankar GG, Bodiwala KJ et al. Development and validation of HPTLC method for simultaneous estimation of lercanidipine hydrochloride and enalapril maleate in their synthetic mixture. J Pharm Appl Sci. 2016;3(2):26-33.
Üstündağ Ö, Dinç E, Özdemir N, Tilkan MG. Comparative application of PLS and PCR methods to simultaneous quantitative estimation and simultaneous dissolution test of zidovudine - lamivudine tablets. Acta Chim Slov. 2015;62(2):437-44. doi: 10.17344/acsi.2014.1071, PMID 26085428.
El Orche A, Adade CA, Mefetah H, Cheikh A, Karrouchi K, El Karbane M et al. Chemometric analysis of UV-visible spectral fingerprints for the discrimination and quantification of clinical anthracycline drug preparation used in oncology. BioMed Res Int. 2021 May 6;2021:5580102. doi: 10.1155/2021/5580102, PMID 34041297, PMCID PMC8121585.
Ahmad I, Sheraz MA, Ahmed S, Anwar Z. Multicomponent spectrometric analysis of drugs and their preparations. Profiles Drug Subst Excip Relat Methodol. 2019;44:379-413. doi: 10.1016/bs.podrm.2018.11.002. PMID 31029223.
Validation of analytical procedures: text and methodology in international conference on harmonisation. Vol. Q2 (R2). Geneva. p. 1-24.
Patel MM, Shah UH, Goswami K, Bhavsar S, Patel SG. Application of chemometric methods for the determination of ciprofloxacin hydrochloride and phenazopyridine hydrochloride in their pharmaceutical dosage form. Rasayan J Chem. 2020;13(4):2361-69. doi: 10.31788/RJC.2020.1345941.
Kumar K. Partial least square (PLS) analysis. Reson. 2021;26(3):429-42. doi: 10.1007/s12045-021-1140-1.
Biancolillo A, Marini F. Chemometric methods for spectroscopy-based pharmaceutical analysis. Front Chem. 2018 Nov 21;6:576. doi: 10.3389/fchem.2018.00576, PMID 30519559, PMCID PMC6258797.
Hemmateenejad B, Akhond M, Samari F. A comparative study between PCR and PLS in simultaneous spectrophotometric determination of diphenylamine, aniline, and phenol: effect of wavelength selection. Spectrochim Acta A Mol Biomol Spectrosc. 2007 Jul;67(3-4):958-65. doi: 10.1016/j.saa.2006.09.014. PMID 17049915.
Prashanthi M, Yaku G, Kasigari CR, UK. Validated UV spectrophotometric methods for the simultaneous estimation of omeprazole and domperidone. Ind J Adv Chem Sci. 2021;9(3):236-42. doi: 10.22607/IJACS.2021.903021.
Sampada S, Mithun SR. Validated simultaneous multicomponent spectrophotometric determination of paracetamol, aceclofenac and tizanidine in tablets. Int J ChemTech Res. 2011;3(2):963-66.
Riddhi G, Rajashree M, Pankaj S. Development and validation of spectrophotometric methods for simultaneous estimation of ibuprofen and paracetamol in soft gelatin capsule by simultaneous equation method. Int J ChemTech Res. 2010;2(4):1881-885.
Wrushali A. Panchale, Ravindra L. Bakal. First-order derivative spectrophotometric estimation of gemifloxacin mesylate and ambroxol HCl in tablet dosage form. GSC Biol and Pharm Sci. 2021;14(2):29-36. doi: 10.30574/gscbps.2021.14.2.0034.
Veena DS, Vijay KS. Development and validation of simultaneous estimation of diclofenac potassium, paracetamol and serratiopeptidase by first order derivative UV spectroscopy method in pharmaceutical formulation. J Chem Pharm Res. 2014;6(5):912-24.
Devi Singh V, Kumar Singh V. Chemo-metric assisted UV-spectrophotometric methods for simultaneous estimation of Darunavir ethanolate and cobicistat in binary mixture and their tablet formulation. Spectrochim Acta A Mol Biomol Spectrosc. 2021 Apr 5;250:119383. doi: 10.1016/j.saa.2020.119383. PMID 33422867.
Khalid MA, Mohammed WN, Ebrahim A. Simultaneous spectrophotometric determination of amlodipine and atenolol in pharmaceutical preparations using chemometric techniques. Anal Chem. 2016;16(5):205-10.
Manwar JV, Nagargoje BU, Gurumukhi VC, Ratnaparkhi DG, Warade PP, Kumbhar DD et al. Application of simultaneous equation method for the determination of azithromycin and cefixime trihydrate in tablet formulation. Res J Pharm Technol. 2017;10(1):108-12. doi: 10.5958/0974-360X.2017.00025.7.
Aa O, RI EB. Development and validation of spectrophotometric methods for the simultaneous determination of mebeverine hydrochloride and chlordiazepoxide in bulk and in dosage form. Pharm Anal Acta. 2016;7(7):501-08. doi: 10.4172/2153-2435.1000501.
Melisew TA, Melisew TM, Abdel-Maaboud BA. Simultaneous spectrophotometric determination of iron (II) and copper (II) in tablets by chemometric methods. Thai J Pharm Sci. 2010;34(3):93-106.
Patel NS, Nandurbarkar VP, Patel AJ, Patel SG. Simultaneous spectrophotometric determination of celecoxib and diacerein in bulk and capsule by absorption correction method and chemometric methods. Spectrochim Acta A Mol Biomol Spectrosc. 2014 May 5;125:46-52. doi: 10.1016/j.saa.2014.01.036. PMID 24530708.
Patel MN, Patel AJ, Shah UH, Patel SG. Comparative Study of the UV Chemometrics, Ratio Spectra Derivative and HPLC-QbD Methods for the Estimation of Their Simultaneous Estimation in Combined Marketed Formulation. Chromatographia. 2021;84(1):75-86. doi: 10.1007/s10337-020-03979-9.
Marwada KR, Patel JB, Patel NS, Patel BD, Borkhatariya DV, Patel AJ. Ultraviolet spectrophotometry (dual wavelength and chemometric) and high performance liquid chromatography for simultaneous estimation of meropenem and sulbactam sodium in pharmaceutical dosage form. Spectrochim Acta A Mol Biomol Spectrosc. 2014 Apr 24;124:292-9. doi: 10.1016/j.saa.2014.01.008. PMID 24495837.
Published
How to Cite
Issue
Section
Copyright (c) 2023 Archita J. Patel, Jamila J. Patel, Samir G. Patel
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
