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Comparative study of the resolution efficiency of HPLC and HPTLC-densitometric methods for the analysis of mebeverine hydrochloride and chlordiazepoxide in their binary mixture
Adel Magdy Michael (1) , Yasmin Mohamed Fayez (2) , Christine Kamal Nessim (3,*) , Hayam Mahmoud Lotfy (4)
(1) Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 6th of October City, 12566, Egypt
(2) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, 11562, Egypt
(3) Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 6th of October City, 12566, Egypt
(4) Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University, 12311 Cairo, Egypt
(*) Corresponding Author
Received: 14 Jun 2016 | Revised: 06 Jul 2016 | Accepted: 14 Jul 2016 | Published: 30 Sep 2016 | Issue Date: September 2016
Accurate, rapid, and selective reversed phase HPLC and HPTLC-densitometric methods with UV detection have been developed and validated for simultaneous determination of a binary mixture of mebeverine hydrochloride (MVH) and chlordiazepoxide (CDZ) in their Co-formulation. For the HPLC method, ACE-126-2546 AQ C-18 column, (250×4.6 mm i.d., 5 μm particle size) in isocratic mode, with mobile phase containing 25 mM ammonium acetate buffer: acetonitrile in the ratio of (60:40, v:v), pH adjusted to 3±0.2 by using hydrochloric acid, the flow rate of 1.0 mL/min and detection was performed at 260 nm. The retention times were 7.23±0.01 and 3.85±0.01 min for MVH and CDZ, respectively. For the HPTLC-densitometric method, the separation was performed using stationary phase pre-coated silica gel 60F254 and mobile phase ethyl acetate: methanol (8:4, v:v) were used and scanned at 222 nm with Camag TLC scanner controlled by Wincats Software. The Rf values were 0.26±0.02 and 0.73±0.01 for MVH and CDZ, respectively. The linearity graphs for MVH and CDZ, respectively, were found to be linear over 1-50 μg/mL and 0.5-40.0 μg/mL with mean percentage recoveries 100.14±0.354 and 99.70±0.764 for HPLC method and 0.5-30.0 μg/band and 1-14 μg/band with mean percentage recoveries 100.29±0.665 and 99.68±0.987 for HPTLC-densitometric method. A comparative study of different analytical validation parameters such as accuracy, precision, specificity, robustness was conducted. The obtained results were statistically compared with those of the official methods; using student t-test, F-test, and one way ANOVA, showing no significant difference with respect to accuracy and precision.
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DOI Link: https://doi.org/10.5155/eurjchem.7.3.315-321.1468
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