Simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in tablet dosage form by RP-HPLC

  • Tejaswini Tonde Project Assistant, Sciedge Abstract Pune, Maharashtra,
  • Halavath Ramesh Department of Chemistry, Loyola College (Autonomous), University of Madras, Chennai, Tamil Nadu
  • Sashank Bhandarkar Project Assistant, Sciedge Abstract Pune, Maharashtra
  • Trupti S. Bobade Scientific Editor, Reschrone Medico Publisher, Nagpur, Maharashtra
  • Sachin Marotrao Hiradeve School of Pharmacy, GH Raisoni University, Saikheda, Chindawara, Madhya Pradesh
Keywords: Phenylephrine Hydrochloride, Cetirizine hydrochloride, Reversed-phase HPLC, Disodium hydrogen phosphate, Methanol, Acetonitrile

Abstract

A simple, economical, specific, accurate, precise and validated Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in synthetic mixture and its combined dosage form. The chromatographic separation was achieved on C18 column (Intersil, 220 mm 4.6 mm i.d., 10 ?m particle size) at ambient temperature using disodium hydrogen phosphate (Na2HPO4) buffer; pH was adjusted to 6.50 using ortho-phosphoric acid and a mobile phase of Methanol: Acetonitrile: Disodium hydrogen phosphate (80: 4: 19, v/v) at flow rate 2.0 ml/min. Quantification was achieved with UV detector at wavelength 270 nm. The retention time was found to be 1.2 0.04 min and 3.1 0.06 min for cetirizine HCl and phenylephrine HCl respectively. The calibration curves were linear with correlation coefficient 0.998 and 0.999 in the range of 10-50 ?g/ml for Cetrizine hydrochloride and Phenylephrine hydrochloride. The methods were validated in terms of linearity, precision, accuracy, LOD, LOQ and ruggedness according to ICH guideline.

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References

. Pesez M, Bartos J. Colourimetric and Fluorimetric Analysis of Organic Compounds and Drugs, Marcel Dekker, New York, 1974; 623630.

. Moffat AC, Jackson JV, Moss MS, Widdop B, Greefield ES. Clarkes Isolation and Identification of Drugs, 2nd ed. The Pharmaceutical Press, London. Fijalek Z, Chodkowski J, Waroma M, Acta Pol. Pharm 1992;49(12):15.

. Dorsey JG, Cooper WT. Retention mechanisms of bonded-phase liquid chromatography. Analytical Chemistry 1994;66(17):857A-867A.

. Zaidi*I, Dr. Joshi D, Dr. Bhadauria Rs. Method Development and Analytical Validation of Levonorgestrel Drug by RP-HPLC Method. IJARPB. 2014; 4(1):1-10.

. Goodman and Gilmans, The Pharmacological Basis of Therapeutics, 10th edition, Mc Graw Hill, Medical Publishing Division. 2001; 409- 413.

. Merck Index - an encyclopedia of chemicals, drugs and biologicals, 13th edition, 7084.

. Indian Pharmacopoeia, Volume-III, Govt. of India, Ministry of Health & Family welfare. The Controller of Publication, Ghaziabad, 2014; 1339 & 2478.

. Dhongle PS, Sahare SJ, Dhongle SS, Mundhey AS, and Wate SP: Development and validation of HPTLC method for simultaneous estimation of Cetirizine hydrochloride and phenylpropanolamine hydrochloride in tablet dosage form. Der Pharmacia Lettre. 2011; 3(4): 111-119.

. Khan IM, Murtaza G, Awan S, Iqbal M, Waqas MK and Rasool A: Development and validation of stability indicating assay method of Cetirizine hydrochloride by HPLC, Afr J Pharm Pharmacology. 2011; 5(2):143-149.

. Maithani M, Raturi R, Vertica G, Kumar D, Gaurav A and Singh R: Simultaneous estimation of Ambroxol hydrochloride and Cetirizine hydrochloride in tablet dosage form by RP-HPLC method. Pharmacie Globale. 2010; 1(2): 1-3.

. Paw B, Misztal G, Hopkala H and Drozd J: Development and validation of a HPLC method for the determination of Cetirizine in pharmaceutical dosage forms. Pharmazie. 2002; 57(5):313-315.

. Savic I, Nikolic G and Bankovic V: Development and validation of spectrophotometric method for Phenylephrine hydrochloride estimation in nasal drop formulations. Maced J Chem Chem Eng. 2008; 27(2):149.

. Malakar P, Deb AR, Adhikary S, Ahmed S and Maloth R: Simultaneous estimation of Phenylepherine HCl, Paracetamol, Caffiene and Ceterizine HCL from tablet dosage form using RP-HPLC. IJBPR. 2013; 4(5):368-376.

. Deshmukh VV, Wagh DD, Vassa SP and Gujar KN: Development of first order ultraviolet spectrophotometric method for simultaneous estimation of Levocetirizine HCl and Phenylepherine HCl in bulk and combined dosage form, Int. Res. J. Pharm. 2013;4(5):115-119.

. Wankhede SB, Lad KA and Chitlange SS: Development and validation of UV-Spectrophotometric methods for estimation of Cetirizine HCl and Phenylepherine HCl in tablets. IJPDR. 2012; 4 (3); 222-226.

. Sawant R, Joshi R, Sawant M, Lanke P and Bhangale L: Mathematucal and multiwavelengh spectrophometric methods for simultaneous estimation of Paracetamol, Phenylepherine HCL, Chlorpheniramine Maleate, and Caffeine. IJPFR 2011; 1(2); 31-38.

. Demiralay EC, Gumustaj M and Canbay H: Validation of method for simultaneous determination of Paracetamol and Phenylepherine HCl in pharmaceutical formulation by RP-HPLC. Pharmacie Globale (IJCP). 2011; 6(09); 1-4.

. Chein D and Schoenwald RD: Flurometric determination of Phenylepherine hydrochloride by liquid chromatography in human plasma. J Pharm Sci.1985; 74(5):562-564.

. Schieffer WG and Hughes ED: Simultaneous stability-indicating determination of Phenylepherine hydrochloride, Phenylpropanolamine hydrochloride and Guaifenesin in dosage forms by reversed phase paired-ion high performance liquid chromatography. Journal of Pharm Sci. 1983; 72(1):55-59.

. ICH, Q2B Validation of analytical procedure: methodology. in: International Conference on Harmonization, Geneva; March, 1996.

Published
2017-12-30
Section
Original Research Articles