Authors:
Shivprasad Deshmukh Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

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Vaishali Musale Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

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Vidhya Bhusari Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

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Sunil Dhaneshwar Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

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A sensitive, simple, selective, precise, and accurate HPTLC method for analysis of alfuzosin hydrochloride (ALF) and dutasteride (DUTA) both as the bulk drugs and in a tablet formulation has been developed and validated. TLC was performed on silica gel 60 F254 with toluene-methanol-dichloromethane-triethylamime 6:1:1:0.6 (ν/ν) as mobile phase. Densitometric evaluation of the separated zones was performed at 247 nm. Compact spots were obtained for ALF (RF 0.46 ± 0.03) and DUTA (RF 0.65 ± 0.03). Linear regression analysis data for the calibration plots revealed good linearity over the concentration ranges 300–600 ng per band for ALF and 500–1000 ng per band for DUTA. The method was validated for linearity, accuracy, precision, robustness, and recovery in accordance with ICH guidelines. There was no chromatographic interference from the tablet excipients. Statistical analysis showed the method enables repeatable and selective simultaneous analysis of these drugs in the tablet formulation and routine quality control of the bulk drug raw materials.

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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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