Validated HPTLC Method for Simultaneous Quantitation of Domperidone Maleate and Naproxen Sodium in Bulk Drug and Formulation
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Department of Pharmaceutical Chemistry, Hon. L.M.C., College of Pharmacy, Faizpur,Jalgaon, India
Bharati Vidyapeeth’s Institute of Pharmacy, Erandwane, Pune, Maharashtra, India
Ravindra Y. Patil   

Department of Pharmaceutical Chemistry, Hon. L.M.C., College of Pharmacy, Faizpur,Jalgaon, India
Publication date: 2017-10-08
Eurasian J Anal Chem 2010;5(3):284–292
This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous quantitation of Domperidone maleate (DOM) and Naproxen sodium (NAP) as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: methanol: acetone (8: 2: 2, v/v/v). Densitometric evaluation of the separated zones was performed at 266 nm. The two drugs were satisfactorily resolved with RF values 0.44 ± 0.02 and 0.56 ± 0.02 for DOM and NAP, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (20–140 for DOM and 500-3500 for NAP), precision (intra-day RSD 0.4–1.01 % and inter-day RSD 0.316–0.876 % for DOM, and intra-day RSD 0.488–1.329 % and interday RSD 0.450–1.026 % for NAP), accuracy (98.38 ± 0.55 % for DOM and 98.64 ± 0.49 % for NAP), and specificity, in accordance with ICH guidelines.
1. (Accessed on January 09, 2009).
O’Neil M J, Smith Ann (2006) The Merck Index, 14th edition Merck and Co., INC. Whitehouse station: New Jersey, p 578.
3. (Accessed on January 09, 2009).
Salem M Y, El-Zanfaly E S, El-Tarras M F (2003) Simultaneous determination of domperidone and cinnarizine in a binary mixture using derivative spectrophotometry, partial least squares and principle component regression calibration. Anal Bioanal Chem 375: 211-216.
Amin A S, Ragab G H (2003) Spectrophotometric methods for the determination of anti-emetic drugs in bulk and in pharmaceutical preparations. Anal Sci 19: 747-751.
Prabu S L, Shirwaikar A (2008) Simultaneous estimation of esomeprazole and domperidone by UV spectrophotometric method. Indian J Pharm Sci 70: 128-131.
Walash M I, Belal F, El-Enany N (2008) Second-derivative synchronous fluorometric method for the simultaneous determination of cinnarizine and domperidone in pharmaceutical preparations: Application to biological fluids. J Fluoresc 18: 61-74.
Abdelal A A, Kitagawa S, Ohtani, H (2008) Method development and validation for the simultaneous determination of cinnarizine and co-formulated drugs in pharmaceutical preparations by capillary electrophoresis. Pharm Biomed Anal 46: 491-507.
Thanikachalam S, Rajappan M, Kannappan V (2008) Stability-indicating HPLC method for simultaneous determination of pantoprazole and domperidone from their combination drug Product. Chromatographia 67: 41-47.
Sivasubramanian L, Anilkumar V (2007) Simultaneous HPLC estimation of omeprazole and domperidone from tablets. India J Pharm Sci 69: 674-676.
Zavitsanos A P, MacDonald C, Bassoo E (1999) Determination of domperidone in human serum and human breast milk by high-performance liquid chromatographyelectrospray mass spectrometry. J Chromatogr B Biomed Sci Appl 730: 9-24.
Patel B H, Suhagia B N, Patel M M (2008) HPTLC determination of rabeprazole and domperidone in capsules and its validation. J Chromatogr Sci 46: 304-307.
Susheel J V, Lekha M, Ravi T (2007) High performance thin layer chromatographic estimation of lansoprazole and domperidone in tablets. Indian J Pharm Sci 69: 684- 686.
Patel B, Patel M, Patel J (2007) Simultaneous determination of omeprazole and domperidone in capsules by RP-HPLC and densitometric HPTLC. J Liquid Chromatogr Related Technol 30: 1749-1762.
Khan I U, Aman T, Ashraf A (1999) Spectrophotometric Determination of naproxen in pure and pharmaceutical preparations. Analytical Lett 32: 2035 – 2050.
Holzbecher M, Ellenberger H A, Marsh J M (1979) An ultraviolet spectrophotometric procedure for the routine determination of naproxen. Clin Biochem12: 66-67.
Haque T, Talukder M U, Laila S (2008) Simultaneous estimation of naproxen and ranitidine HCl by using UV spectrophotometer. J Pharm Sci 1:18-24.
Mortensen A, Jensen E B, Petersen P B (1979) The determination of naproxen by spectrofluorometry and its binding to serum proteins. Acta Pharmacol Toxicol (Copenh) 44: 277-283.
Damiani P C, Borraccetti M D, Olivieri A C (2002) Direct and simultaneous spectrofluorometric determination of naproxen and salicylate in human serum assisted by chemometric analysis. Anal Chim Acta 471: 87-96.
Buyuktimkin N, Buyuktimkin S, Grunow D (1988) The use of activated (S)- (+)- naproxen for the gas chromatographic resolution of some amino acid methyl esters. Chromatographia 25: 925-927.
Chen Y L, Wu S M (2005) Capillary zone electrophoresis for simultaneous determination of seven nonsteroidal anti-inflammatory drugs in pharmaceuticals. Anal Bioanal Chem 381: 907- 912.
Tashtoush B M, Al-Taani B M (2003) HPLC determination of naproxen in plasma. Pharmazie 58: 614-615.
Hsu Y H, Liou Y B, Lee J A (2006) Assay of naproxen by high- performance liquid chromatography and identification of its photoproducts by LC-ESI MS. Biomed chromatogr 20: 787-793.
Martin M J, Pablos F, Gonzalez A G (1999) Simultaneous determination of caffeine and non-steroidal anti-inflammatory drugs in pharmaceutical formulations and blood plasma by reversed-phase HPLC from linear gradient elution. Talanta 49: 453-459.
Guermouche M H, Atik N, Chader H (2000) Assay of naproxen in rat serum by highperformance thin layer chromatography/Densitometry. J AOAC Int 83: 1489-1492.
Lippstone M B, Sherma J (1995) Analysis of tablets containing naproxen and ibuprofen by HPTLC with ultraviolet absorption densitometry. J Planar chromatogr 8: 427-429.
Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH Harmonised Tripartite Guideline, Nov 2005.