MULTICOMPONENT SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ANALYSIS OF DELAPRIL AND INDAPAMIDE IN TABLETS

Vitor Todeschini, Regiane Leite, Maximiliano Sangoi, Paulo Oliveira, Thiago Barth

Abstract


A multicomponent ultraviolet (UV) spectrophotometric method was developed and validated for simultaneous determination of delapril (DEL) and indapamide (IND) in tablets employing the partial least squares regression (PLSR) approach. The PLSR method was developed by a multilevel factorial design using 25 synthetic mixtures of drugs and a significant predict model (p < 0.05) were obtained at 225 nm for DEL (r2= 0.9992) and 243 nm for IND (r2= 0.9997). Validation parameters such as the specificity, linearity, precision, accuracy and robustness were evaluated in accordance with the ICH requirements, giving satisfactory results within the acceptable range. The proposed PLSR method was successfully applied for simultaneous determination of DEL and IND in fixed dose combinations and can be used as simple alternative to separation techniques.


Full Text:

PDF

References


(1) Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJL. Global burden of disease and risk factors. Lancet. 2006; 367: 1747-1757.

(2) Gradman AH, Basile JN, Carter BL, Bakris GL. Combination therapy in hypertension. J Am Soc Hypertens. 2010; 4(1): 42-50.

(3) Cavalieri L, Cremonesi G. Delapril plus indapamide: a review of the combination in the treatment of hypertension. Clin Drug Invest. 2007; 27: 367-380.

(4) Circelli M. Efficacy and safety of delapril/indapamide compared to different ACE-inhibitor/hydrochlorothiazide combinations: a meta-analysis. Int J Gen Med. 2012; 5: 725-734.

(5) Todeschini V, Meira AS, Sangoi MS, Barth AB, Paim CS, Volpato NM. Simultaneous determination of delapril and manidipine in a pharmaceutical formulation by a stability-indicating RP-LC method. J Liq Chromatogr Rel Technol. 2012; 35: 603-620.

(6) Todeschini,V, Sangoi MS, Volpato NM. Delapril and manidipine measurements by liquid chromatography-tandem mass spectrometry in pharmaceutical formulation. Eur J Mass Spectrom. 2011; 17: 287-296.

(7) Todeschini V, Meira AS, Sangoi MS, Miron D, Lange AD, Volpato NM. Stability-indicating micellar electrokinetic chromatography technique for simultaneous measurement of delapril and manidipine from their combination drug formulation. J AOAC Int. 2014; 97: 114-120.

(8) Todeschini V, Barden AT, Sfair LL, Sangoi MS, Volpato NM. First-order derivative UV spectrophotometric method for simultaneous measurement of delapril and manidipine in tablets. Acta Chim Slov. 2013; 60(2): 335-342.

(9) Rojas F, Ojeda C. Recent development in derivative ultraviolet/visible absorption spectrophotometry: 2004-2008: A review. Anal. Chim. Acta. 2009; 635: 22-44.

(10) Ayoub BM. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation. Spectrochim. Acta A: Mol Biomol Spectrosc. 2016; 168: 118-122.

(11) Darwish HW, Bakheit AH, Abdelhameed AS. Simultaneous quantitative analysis of olmesartan, amlodipine and hydrochlorothiazide in their combined dosage form utilizing classical and alternating least squares based chemometric methods. Acta Pharm. 2016; 66: 83-95.

(12) Glavanović S, Glavanović M, Tomišić V. Simultaneous quantitative determination of paracetamol and tramadol in tablet formulation using UV spectrophotometry and chemometric methods. Spectrochim Acta A: Mol Biomol Spectrosc. 2016; 157: 258-264.

(13) Abdel-Halim LM, Abd-El Rahman MK, Ramadan NK, El Sanabary HF, Salem MY. Comparative study between recent methods manipulating ratio spectra and classical methods based on two-wavelength selection for the determination of binary mixture of antazoline hydrochloride and tetryzoline hydrochloride. Spectrochim Acta A: Mol Biomol Spectrosc. 2016; 159: 98-105.

(14) Palabiyik IM, Onur F, Yardimci C, Özaltin N. Simultaneous spectrophotometric determination of ezetimibe and simvastatin in pharmaceutical preparations using chemometric techniques. Quim Nova. 2008; 31(5): 1121-1124.

(15) International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use. Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva, Switzerland, 2005. 17p.

(16) Food and Drug Administration (FDA), Center for Drug Evaluation and Research. Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics. Silver Spring, USA, 2015. 18p.




DOI: https://doi.org/10.22456/2527-2616.74119

Refbacks

  • There are currently no refbacks.


Copyright (c) 2017

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.