JPC - Journal of Planar Chromatography - Modern TLC
Volume/Issue:
Volume 25: Issue 1
Development and validation of a stability-indicating HPTLC method for the determination of mirtazapine as bulk drug and in pharmaceutical formulation
Authors:
Laxman Potale AISSMS College of Pharmacy Department of Pharmaceutical Chemistry Kennedy Road, Near RTO Pune 411001 Maharashtra India

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Amol Khodke AISSMS College of Pharmacy Department of Pharmaceutical Chemistry Kennedy Road, Near RTO Pune 411001 Maharashtra India

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Shangiresh Patole AISSMS College of Pharmacy Department of Pharmaceutical Chemistry Kennedy Road, Near RTO Pune 411001 Maharashtra India

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, and
Mrinalini Damle AISSMS College of Pharmacy Department of Pharmaceutical Chemistry Kennedy Road, Near RTO Pune 411001 Maharashtra India

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Pages:
72–76
Online Publication Date:
31 Jan 2012
Publication Date:
01 Feb 2012
Article Category:
Research Article
DOI:
https://doi.org/10.1556/jpc.25.2012.1.12
Keywords:
Mirtazapine; High-performance thin-layer chromatography (HPTLC); Stability indicating
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Asensitive, selective, precise, and stability-indicating (in accordance with ICH guidelines) high-performance thin-layer chromatography (HPTLC) method of analysis for mirtazapine was developed to resolve the drug response from that of its degradation products. TLC aluminum plates precoated with silica gel 60 F254 were used as the stationary phase. The solvent system consisted of methanol-chloroform, 9:1 (v/v). This system was found to give a compact spot for mirtazapine (RF value 0.56 ± 0.03). Mirtazapine was subjected to stress test conditions such as acid, alkali, neutral hydrolysis, oxidation, dry heat, and photodegradation. The spots for the product of degradation were well resolved from those of the drug. Densitometric analysis of drug was carried out in the absorbance mode at 294 nm. The linear regression data for the calibration plots showed good linear relationship with an r2 value of 0.994 in the concentration range 400–2000 ng/band. The result indicates that the drug was susceptible to degradation but to different extents under different conditions.

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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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