Turbidimetric Determination of Mebeverine Hydrochloride in Pharmaceutical Formulations Using Two Consecutive Detection Zones under Continuous Flow Conditions

2022;
: pp. 600 - 613
1
University of Baghdad, College of Science, Department of Chemistry
2
Universities of Baghdad, College of Science, Department of Chemistry

A simple, low cost and rapid flow injection turbidimetric method was developed and validated for mebeverine hydrochloride (MBH) determination in pharmaceutical preparations. The developed method is based on forming of a white, turbid ion-pair product as a result of a reaction between the MBH and sodium persulfate in a closed flow injection system where the sodium persulfate is used as precipitation reagent. The turbidity of the formed complex was measured at the detection angle of 180° (attenuated detection) using NAG dual&Solo (0-180°) detector which contained dual detections zones (i.e., measuring cells 1 & 2). The increase in the turbidity of the complex was directly proportional to the increase of the MBH concentration in the range of 2.0-10 µmol/L with a limit of detection 0.35 µmol/L, 0.9981 (R2), and 2.0-12 µmol/L with a limit of detection 0.4 µmol/L and 0.9973 (R2) for measuring cells 1 and 2, respectively. The intra-day precision for three serial estimations of 5.0 and 9.0 µmol/L of MBH exhibited an RSD % of 0.23 % and 0.77 % and 0.68 % and 0.13 %, for cell 1 & 2, respectively. While the inter-day precision for three serials of three days exhibited an RSD % of 0.03 % and 0.77 % and 0.11 % and 0.07 %, for measuring cells 1 & 2, respectively. The accuracy of the developed method has expressed as an error % (E%) and a Rec % (recovery percentage), which was between 100.35 to 101.15 and 99.70 to 101.56 for cell 1 and cell 2, respectively. The present flow injection method has shown no interference effect from the common excipients and permits quantitively determination of 60 samples per hour. The developed method was successfully applied for the quantitative determination of MBH in different tablets containing 135 mg with excellent recovery percentage.

[1] Othman, A.A.; El-Bagary, R. 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, 13, 1000501. https://doi.org/10.4172/2153-2435.1000501
[2] Pharmacopoeia, B. British pharmacopoeia, 2016. (Book Online)
[3] Commission, B.P., G.B.M. Commission, and G.M. Council, British Pharmacopoeia 2000. Vol. 1. 2000: Bernan Press (PA).
[4] Abd Elhady, Seham S.; Mortada, Naheed D.; Awad, Gehanne A.S.; Zaki, Noha M. Development of in Situ Gelling and Muco Adhesive Mebeverine Hydrochloride Solution for Rectal Administration. Saudi Pharm. J. 2003, 11, 159-171.
[5] Hosny, E.A.; Abdel-Hady, S.S.; El-Tahir, K.E.H. Formulation, in-vitro Release and ex-vivo Spasmolytic Effects of Mebeverine Hydrochloride Suppositories Containing Polycarbophil or Polysorbate 80. Int. J. Pharm. 1996, 142, 163-168. https://doi.org/10.1016/0378-5173(96)04664-9
[6] Krishnaiah, Y.S.R.; Satyanarayana, S. Colon-Specific Drug Delivery Systems. In Advances in Controlled and Novel Drug Delivery; CBS Publishers and Distributors: New Delhi, India, 2001; pp 89-119.
[7] Elzanfaly, E.S.; Hegazy, M.A.; Samah S. Saad, S.S.; Salem, M.Y.; Abd El Fattah, L.E. Validated Green High-Performance Liquid Chromatographic Methods for the Determination of Coformulated Pharmaceuticals: A Comparison with Reported Conventional Methods. J. Sep. Sci. 2015, 38, 757-763. https://doi.org/10.1002/jssc.201401151
[8] Radwan, M.A.; Abdine, H.H.; Aboul-Enein, H.Y. A Validated Chiral HPLC Method for the Determination of Mebeverine HCl Enantiomers in Pharmaceutical Dosage forms and Spiked rat Plasma. Biomed. Chromatogr. 2006, 20, 211-216. https://doi.org/10.1002/bmc.556
[9] Hatami, M.; Farhadi, K.; Tukmechi, A. Fiber-Based Liquid-Phase Micro-Extraction of Mebeverine Enantiomers Followed by Chiral High-Performance Liquid Chromatography Analysis and Its Application to Pharmacokinetics Study in Rat Plasma. Chirality 2012, 24, 634-639. https://doi.org/10.1002/chir.22057
[10] Elmasry, M.S.; Blagbrough, I.S.; Rowan, M.G.; Saleh, H.M.; Kheir, A.A.; Rogers, P.J. Quantitative HPLC Analysis of Mebeverine, Mesalazine, Sulphasalazine and Dispersible Aspirin Stored in a Venalink Monitored Dosage System with Co-Prescribed Medicines. J. Pharm. Biomed. Anal. 2011, 54, 646-652. https://doi.org/10.1016/j.jpba.2010.10.002
[11] Heneedak, H.M.; Salama, I.; Mostafa, S.; El-Sadek, M. A Stability-indicating HPLC Method for the Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Commercial Tablets. Curr. Anal. Chem. 2014, 10, 565-573. https://doi.org/10.2174/15734110113099990040
[12] Lotfy, H.M.; Fayez, Y.M.; Michael, A.M.; Nessim, C.K. Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Their Binary Mixture Using Novel Univariate Spectrophotometric Methods via Different Manipulation Pathways. Spectrochim. Acta A Mol. Biomol. Spectrosc. 2016, 155, 11-20. https://doi.org/10.1016/j.saa.2015.10.033
[13] Mahdi, A.; Abas, Z. Spectrophotometric Determination of Mebeverine Hydrochloride In Pharmaceutical Preparation via Ion Association Reaction. J. Phys. Conf. Ser. 2018, 1032, 012064. https://doi.org/10.1088/1742-6596/1032/1/012064
[14] Nezhadali, A.; Bonakdar G.A. Multivariate optimization of Mebeverine Analysis Using Molecularly Imprinted Polymer Electrochemical Sensor Based on Silver Nanoparticles. J. Food Drug Anal. 2019, 27, 305-314. https://doi.org/10.1016/j.jfda.2018.05.002
[15] Salama, N.N.; Zaazaa, H.E.; Azab, S.M.; Atty, S.A.; Naglaa M. El-Kosy, N.M.; Salem, M.Y. Utility of Gold Nanoparticles/Silica Modified Electrode for Rapid Selective Determination of Mebeverine in Micellar Medium: Comparative Discussion and Application in Human Serum. Ionics (Kiel) 2016, 22, 957-966. https://doi.org/10.1007/s11581-015-1602-0
[16] Ibrahim, H.; Issa, Y.M.; Abu-Shawish, H.M. Potentiometric Flow Injection Analysis of Mebeverine Hydrochloride in Serum and Urine. J. Pharm. Biomed. Anal. 2005, 36, 1053-1061. https://doi.org/10.1016/j.jpba.2004.08.032
[17] Lakshmi, M.V.; Pavani, M.; Rao, G.D. Rp – Hplc Method for Determination of Mebeverine Hydrochloride in Dosage Forms Employing Ms Compatible Buff Ers. Indian Drugs 2020, 57, 69-72 https://doi.org/10.53879/id.57.03.11722
[18] Senthil Kumar, K.R.; Meyyanathan, S.N.; Gowramma, B. Chiral Rp-HPLC Method for Enantiomeric Separation of Mebeverine Hydrochloride in Formulations. Indo Am. J. Pharm. Sci. 2015, 5, 2756-2764
[19] Chhalotiya, U.K.; Patel, N.M.; Shah, D.A.; Mehta, F.A.; Bhatt, K.K. Thin-Layer Chromatography Method for the Simultaneous Quantification and Stability Testing of Alprazolam and Mebeverine in Their Combined Pharmaceutical Dosage Form. J. Taibah Univ. Medical Sci. 2017, 11, 66-75. https://doi.org/10.1016/j.jtusci.2015.06.012
[20] El-Desoky, H.S.; Ghoneim, M.M.; El-Badawy, F.M. Carbon Nanotubes Modified Electrode for Enhanced Voltammetric Sensing of Mebeverine Hydrochloride in Formulations and Human Serum Samples. J. Electrochem. Soc. 2017, 164, B212-B222. https://doi.org/10.1149/2.0941706jes
[21] Walash, M.I.; Mohie M Kh Sharaf El-din; Nahed M. El-Enany; Manal I. Eid; Shereen M. Shalan. Simultaneous Determination of Sulpiride and Mebeverine by HPLC Method Using Fluorescence Detection: Application to Real Human Plasma. Chem. Cent. J. 2012, 6, 13. https://doi.org/10.1186/1752-153X-6-13
[22] Derayea, S.M.S. An Application of Eosin Y for the Selective Spectrophotometric and Spectrofluorimetric Determination of Mebeverine Hydrochloride. Anal. Methods 2014, 6, 2270-2275. https://doi.org/10.1039/C3AY41371C
[23] Panda, S.S.; Kumar Bera, V.V.R.; Sahoo, P.; Sahu, B. Quantitative Estimation of Mebeverine Hydrochloride in Sustained-Release Dosage Form Using an Analytical Lifecycle Management Oriented Stability-Indicating LC Method. J. Liq. Chromatogr. Relat. Technol. 2018, 41, 637-644. https://doi.org/10.1080/10826076.2018.1500376
[24] Naguib, I.A.; Abdelkawy, M. Development and Validation of Stability Indicating HPLC and HPTLC Methods for Determination of Sulpiride and Mebeverine Hydrochloride in Combination. Eur. J. Med. Chem. 2010, 45, 3719-3725. https://doi.org/10.1016/j.ejmech.2010.05.021
[25] Srinivasan, V.; Sivaramakrishnan, H.; Karthikeyan, B.; Balaji T.S.; Vijayabaskar, S. Stress Degradation Studies on Mebeverine Hydrochloride and Development of a Validated Stability Indicating UPLC Method. J. Liq. Chromatogr. Relat. Technol. 2011, 34, 1631-1644. https://doi.org/10.1080/10826076.2011.576297
[26] Al Lawati, H.A. J.; Al Dahmani, Z.M.; Varma, G.B.; Suliman, F.E.O. Photoinduced Oxidation of a Tris(2,2'-bipyridyl)ruthenium(II)–peroxodisulfate Chemiluminescence System for the Analysis of Mebeverine HCl Pharmaceutical Formulations and Biological Fluids Using a Two-Chip Device. Luminescence. 2014, 29, 275-283. https://doi.org/10.1002/bio.2540
[27] Turkey, N.S.; Jeber, J.N. A Flow Analysis System Integrating an Optoelectronic Detector for the Quantitative Determination of Active Ingredients in Pharmaceutical Formulations. Microchem. J. 2021, 160, 105710. https://doi.org/10.1016/j.microc.2020.105710
[28] Jeber, J.; Turkey, N.S. A Turbidimetric Method for the Quantitative Determination of Cyproheptadine Hydrochloride in Tablets Using an Optoelectronic Detector Based on the LEDs Array. Int. J. Pharm. Res. 2020, 12, 2911. https://doi.org/10.31838/ijpr/2020.12.04.401
[29] Jeber, J.N. Quantitative Determination of Ephedrine Hydrochloride in Pharmaceutical Injections by Highly Sensitive Turbidimetric and Reversed-Phase Combined with UFLC Methods. Chem. Chem. Technol. 2019, 13, 269-274. https://doi.org/10.23939/chcht13.02.269
[30] Hammood, M.K.; Jeber, J.N.; Muhamad, Y.H. Two Techniques (Spectrophotometric and Turbidimetric) for Determination of Ciprofloxacin HCl in Pharmaceutical Drugs with Comparison between the Techniques. Iraqi J. Sci. 2016, 57, 1620-1628.
[31] Ertokus, G.; Tugrul, A. Spectrophotometric Determination of Acetylsalicylic Acid, Paracetamol and Ascorbic Acid by Chemometric Methods. Chem. Chem. Technol. 2018, 12, 279-284. https://doi.org/10.23939/chcht12.03.279
[32] Smolinska, M.; Коrkunа, O.; Vrublevska, T.; Tеslyar, G. Eriochrome Black T – A New Analytical Reagent for Spectrophotometric Determination of Sulphanilamides. Chem. Chem. Technol. 2015, 9, 401-410. https://doi.org/10.23939/chcht09.04.401
[33] Solodovnik, T.; Stolyarenko, H.; Slis, A.; Kultenko, V. Study of Heat Treatment Effect on Structure and Solubility of Chitosan Films. Chem. Chem. Technol. 2017, 11, 175-179. https://doi.org/10.23939/chcht11.02.175
[34] Menard, K.; Brostow, W.; Menard, N. Photodegradation of Pharmaceuticals Studied with UV Irradiation and Differential Scanning Calorimetry. Chem. Chem. Technol. 2011, 5, 385-388. https://doi.org/10.23939/chcht05.04.385
[35] Nazari, G.; Abolghasemi, H.; Esmaieli, M. Study of Mass Transfer Coefficient of Cephalexin Adsorption onto Walnut Shell-Based Activated Carbon in a Fixed-Bed Column. Chem. Chem. Technol. 2016, 10, 81-86. https://doi.org/10.23939/chcht10.01.081
[36] British Pharmacopoeia, Vols I & II; Her Majesty's Stationery Office: London, 1988.