Abstract
A simple, sensitive and rapid spectrofluorimetric method for determination of itopride hydrochloride in raw material and tablets has been developed. The proposed method is based on the measurement of the native fluorescence of the drug in water at 363 nm after excitation at 255 nm. The relative fluorescence intensity-concentration plot was rectilinear over the range of 0.1–2 μg/mL (2.5 × 10−7–5.06 × 10−6 mole/L), with good correlation (r = 0.9999), limit of detection of 0.015 μg/mL and a lower limit of quantification of 0.045 μg/mL. The described method was successfully applied for the determination of itopride hydrochloride in its commercial tablets with average percentage recovery of 100.11 ± 0.32 without interference from common excipients. Additionally, the proposed method can be applied for determination of itopride in combined tablets with rabeprazole or pantoprazole without prior separation. The method was extended to stability study of itopride. The drug was exposed to acidic, alkaline, oxidative and photolytic degradation according to ICH guidelines. Moreover, the method was utilized to investigate the kinetics of the alkaline, acidic and oxidative degradation of the drug. A proposal for the degradation pathways was postulated.
Similar content being viewed by others
References
Sweetman S (ed) (2009) Martindale, the complete drug reference, 36th edn. The Pharmaceutical Press, London, p 1737
Gupta KR, Joshi RR, Chawla RB, Wadodkar SG (2010) UV spectrophotometric method for the estimation of itopride hydrochloride in pharmaceutical formulation. E-J Chem 7:49–54
Zate SU, Kothawade PI, Gajbe JW, Pramod AS, Boraste SS (2010) Spectrophotometric method development and validation of itopride hydrochloride in bulk and dosage form. Int J Drug Deliv 2:340–343
Choudhary B, Goyal A, Khokra SL (2009) New visible spectrophotometric method for estimation itopride hydrochloride from tablets formulations using methyl orange reagent. Int J Pharm Pharm Sci 1(1):159–162
Sabnis SS, Dhavale ND, Jadhav VY, Gandhi SV (2008) Spectrophotometric simultaneous determination of rabeprazole sodium and itopride hydrochloride in capsule dosage form. Spectrochim Acta Part (A) 69:849–852
Heralgi RV, Simpi CC, Kalyane NV, Karajgi SR (2008) Simultaneous spectrophotometric estimation of rabeprazole sodium and itopride hydrochloride in capsule formulations. Asian J Pharm 2(3):148–149
Pillai S, Singhvi I (2008) Quantitative estimation of itopride hydrochloride and rabeprazole sodium from capsule formulation. Indian J Pharm Sci 70(5):658–661
Pattanayak P, Sharma R, Chaturvedi SC (2007) Simultaneous spectrophotometric estimation of rabeprazole sodium and itopride hydrochloride. Anal Lett 40(12):2288–2294
Sabnis SS, Gandhi SV, Madgulkar AR, Bothara KG (2007) Simultaneous determination of rabeprazole sodium and itopride hydrochloride by spectrophotometry. Hindustan Antibiot Bull 49:34–38
Hun XU, Zhang Z (2008) Electrogenerated chemiluminescence sensor for itopride with Ru(bpy)3 +2doped silica nanoparticles/chitosan composite films modified electrode. Sensors Actuators B 131:403–410
Suganthi A, John S, Ravi TK (2008) Simultaneous HPTLC determination of rabeprazole and itopride hydrochloride from their combined dosage form. Indian J Pharm Sci 70(3):366–368
Dighe VV, Sane RT, Menon SN, Tambe HN, Pillai S (2006) High performance thin layer chromatographic determination of itopride hydrochloride in its pharmaceutical preparation and in the bulk drug. J Planar Chromatogry-Mod TLC 19:319–323
Thiruvengada RV, Mohamed STS, Ramkanth S, Alagusundaram M, Ganaprakash K, Madhusudhana CC (2010) A simple RP-HPLC method for quantitation of itopride HCl in tablet dosage form. J Young Pharm 2(4):410–413
Gupta KR, Chawla RB, Wadodkar SG (2010) Stability indicating RP-HPLC method for simultaneous determination of pantoprazole sodium and itopride hydrochloride in bulk and capsule. Orbital Elec J Chem 2(3):209–224
Umamaheswari D, Kumar M, Jayakar B, Chatakonda R (2010) Method development and validation of itopride hydrochloride and rabeprazole sodium in pharmaceutical dosage form by reversed phase high performance liquid chromatography. J Chem Pharm Res 2(5):399–417
Patel BH, Suhagia BN, Patel MM, Patel JR (2007) Determination of pantoprazole, rabeprazole, esomeprazole, domeperidone and itopride in pharmaceutical products by reversed phase liquid chromatography using single mobile phase. Chromatographia 65:743–748
Kaul N, Agrawal H, Maske P, Rao JR, Ramoomahadik K, Kadam SS (2005) Chromatographic determination of itopride hydrochloride in presence of its degradation products. J Sep Sci 28:1566–1576
Sun Y, Zhang Z, Xi Z, Shi Z, Tian W (2009) Determination of itopride hydrochloride by high-performance liquid chromatography with Ru(bpy)3 +2 electrogenerated chemiluminescence detection. Anal Chim Acta 648:174–177
Ptacek P, Klima J, Macek J (2009) Optimized method for the determination of itopride in human plasma by high-performance liquid chromatography with fluorimetric detection. J Chromatogr B 877:842–846
Ma J, Yuan LH, Ding MJ, Zhang J, Zhang Q, Xu QW, Zhou XM (2009) Determination of itopride hydrochloride in human plasma by RP-HPLC with fluorescence detection and its use in bioequivalence study. Pharmacol Res 59(3):189–193
Singh SS, Jain M, Sharma K, Shah B, Vyas M, Thakkar B, Shah R, Singh S, Lohray B (2005) Quantitation of itopride in human serum by high-performance liquid chromatography with fluorescence detection and its application to a bioequivalence study. J Chromatogr B 818(2):213–220
Bose A, Bhaumik U, Ghosh A, Chatterjee B, Chakrabarty US, Sarkar AK, Pal TK (2009) LC-MS simultaneous determination of itopride hydrochloride and domperidone in human plasma. Chromatographia 69:1233–1241
Lee HW, Seo JH, Choi SK, Lee KT (2007) Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: application to a bioequivalence study. Anal Chim Acta 583(1):118–123
ICH Harmonized Tripartite Guideline: validation of analytical procedures. Text and methodology, Q2(R1) current step 4 version, parent guidelines on methodology dated November 1996, Incorporated in November 2005. http://www.ich.org/LOB/media/MEDIA417.pdf (accessed February 15, 2008)
Aulton ME (ed) (2002) Pharmaceutics—the science of dosage form design, 2nd edn. Churchill Livingstone, Toronto, pp 129–132
Miller JC, Miller JN (2005) Statistics and chemometrics for analytical chemistry, 5th edn. Pearson Education Limited, Harlow
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Walash, M.I., Ibrahim, F., Eid, M.I. et al. Stability-Indicating Spectrofluorimetric Method for Determination of Itopride Hydrochloride in Raw Material and Pharmaceutical Formulations. J Fluoresc 23, 1293–1300 (2013). https://doi.org/10.1007/s10895-013-1263-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10895-013-1263-1