JPC - Journal of Planar Chromatography - Modern TLC
Volume/Issue:
Volume 30: Issue 4
Stability-indicating high-performance liquid chromatography and thin-layer chromatography methods for the determination of cyclobenzaprine hydrochloride and asenapine maleate
Authors:
Nesrin K. Ramadan Cairo University, Egypt

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,
Tagreed A. Mohamed National Organization for Drug Control and Research, 9 Abou-Hazem Str., Giza, Egypt

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,
Rowayda M. Fouad National Organization for Drug Control and Research, 9 Abou-Hazem Str., Giza, Egypt

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, and
Azza A. Moustafa Cairo University, Egypt

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Pages:
313–322
Online Publication Date:
Aug 2017
Publication Date:
01 Aug 2017
Article Category:
Rapid Communication
DOI:
https://doi.org/10.1556/1006.2017.30.4.12
Keywords:
Stability-indicating methods; Cyclobenzaprine HCl; Asenapine maleate; High-performance liquid chromatography; Thin-layer chromatography; Validation
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Two sensitive, specific, and selective stability-indicating chromatographic methods were developed for the determination of cyclobenzaprine HCl (CZ) and asenapine maleate (AS) in pure forms, in the presence of their degradation products and in their pharmaceutical formulations. The first method was an isocratic reversed-phase high-performance liquid chromatography (RP-HPLC). Analysis was performed on cyano column using a mobile phase consisting of acetonitrile–(0.05 m) potassium dihydrogen phosphate buffer (pH 3 ± 0.1) (70:30, v/v) with a flow rate of 1.5 mL min−1 and ultraviolet (UV) detection at 290 nm for the determination of CZ, and methanol–(0.05 m) potassium dihydrogen phosphate buffer (pH 6 ± 0.1) (70:30, v/v) with a flow rate of 1.5 mL min−1 and UV detection at 220 nm for the determination of AS. The second method was thin-layer chromatography (TLC), using silica gel 60 F254 plates and toluene–methanol–chloroform-ammonia solution 33% (5:3:6:0.1, by volume) as the mobile phase for the two drugs. The spots were scanned densitometrically at 290 and 220 nm for the determination of CZ and AS, respectively. The methods were validated according to the International Conference on Harmonization (ICH) guidelines, and the acceptance criteria for linearity, accuracy, precision, specificity, and system suitability were met in all cases. The linearity ranges were 2.5–25 μg mL−1 for the RP-HPLC method and 5–50 μg band−1 for the TLC method for both drugs. The limits of detection for the RP-HPLC method were 0.250 and 0.578 for CZ and AS, respectively, while the limits of quantification were 0.758 and 1.572 for CZ and AS, respectively. The limits of detection for the TLC method were 1.355 and 1.284 for CZ and AS, respectively, while the limits of quantification were 4.472 and 3.891 for CZ and AS, respectively. The results were compared statistically at a 95% confidence level with the reported methods. There were no significant differences between the mean percentage recoveries and the precisions of the two methods.

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Cover JPC - Journal of Planar Chromatography - Modern TLC
JPC - Journal of Planar Chromatography - Modern TLC
Print ISSN:
0933-4173
Online ISSN:
1789-0993

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Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation		 1988
Volumes
per Year		 1
Issues
per Year		 6
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

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