Validated HPTLC method for simultaneous quantitation of famotidine and domperidone in bulk drug and formulation
Keywords:
Thin Layer Chromatography, Densitometry, Validation, Quantification, Famotidine, DomperidoneAbstract
This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous quantitation of famotidine (FAM) and domperidone (DOM) as the bulk drug and in tablet dosage forms. 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 n-butanol: water 6: 1(v/v). Densitometric evaluation of the separated zones was performed at 280 nm. The two drugs were satisfactorily resolved with RF values 0.27±0.01 and 0.58±0.01 for FAM and DOM, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (200-1200 ng.spot-1 for FAM and 100-600 ng.spot-1 for DOM), precision (intra-day RSD 0.05–0.40 % and inter-day RSD 0.13–0.39 % for FAM, and intra-day RSD 0.10–0.20 % and inter-day RSD 0.13–0.60 % for DOM), accuracy (99.10±0.116 % for FAM and 98.57±1.078 % for DOM), and specificity, in accordance with ICH guidelines.
References
Goodman G, The Pharmacological Basis of
Therapeutics, 9th Ed., McGraw-Hill, New York
, pp. 904 – 907.
Langtry HD, Wilde MI. Proton pump inhibitors.
Drugs 1998; 56:447–486.
Budavari S, Ed. The Merck Index, 13th ed.; Merck
and Co. Inc.: Whitehouse Station, New Jersey,
, 6306, 3476.
Abu Zuhi A, Shubietah R, Badah G. Extractionalspectrophotometric determination of famotidine in
pharmaceutical formulations. J Pharm Biomed
Anal 1999; 21:459 – 465.
Kelani K, Azziz A, Hegazy M, Abdel Fattah L.
Different spectrophotometric methods for the
determination of cimetidine, ranitidine
hydrochloride, and famotidine. Spectrosc Lett
; 35:543 – 563.
Amin A, Shama S, Ahmed I, Gouda E.
Spectrophotometric determination of famotidine
through oxidation with n-bromosuccinimide and
cerric sulphate. Anal Lett 2002, 35:1851 – 1862.
Nassr S, Brunet M, Lavoie P, Brazier J. HPLC–
DAD method for studying the stability of solutions
containing morphine, dexamethasone, haloperidol,
midazolam, famotidine, metoclopramide, and
dimenhydrinate. J Liq Chromatogr Related
Technol 2001;24: 265 – 281.
Rahman N, Kasihif M. Application of ninhydrin to
spectrophotometric determination of famotidine in
drug formulations. Farmaco 2003; 58: 1045 –
Ayed M, Shalaby A, Abdellatef H, Elsaid H.
Potentiometric determination of famotidine in
pharmaceutical formulations. J Pharm Biomed
Anal 2002; 29, 247 – 254.
Chang Z, Zheng X. Highly sensitive
electrogenerated chemiluminescence (ECL)
method for famotidine with pre-anodizing
technique to improve ECL reaction
microenvironment at graphite electrode surface. J
Electroanal Chem 2006; 587:161 – 168.
Helali N, Adhoum N, Monser L. Flow injection
kinetic spectrophotometric method for the
determination of famotidine in pharmaceutical
preparations. J Flow Inject Anal 2005; 22:129 –
Altria K, Marsh A, Sanger-van de Griend C.
Capillary electrophoresis for the analysis of smallmolecule pharmaceuticals. Electrophoresis 2006;
:2263 – 2282.
Altria K. Overview of capillary electrophoresis and
capillary electrochromatography. J Chromatogr
A 1999; 856:443 – 463.
Altria K, Elder D. Overview of the status and
applications of capillary electrophoresis to the
analysis of small molecules. J Chromatogr A 2004;
:1 – 14.
Chih H, Hsi-Min H, Shu-Ying H, Ching-Yih S,
Ber-Lin C. Simultaneous high- performance
liquid chromatographic analysis for famotidine,
ranitidine HCl, cimetidine, and nizatidine in
commercial products. Drug Dev Ind Pharm 1999;
:379 – 385.
Dowling T, Frye R. Determination of famotidine in
human plasma and urine by high-performance
liquid chromatography. J Chromatogr B 1999;
:239 – 243.
Zoest A, Wanwimoluk S, Hung C. Simultaneous
high-performance liquid chromatographic
analysis for famotidine, ranitidine HCl, cimetidine,
and nizatidine in commercial Products. J
Chromatogr B 1991; 572: 227 – 238.
