title: Development and Validation of Stability-Indicating HPTLC Method for Estimation of Naratriptan Hydrochloride in Its Pharmaceutical Dosage Form and Its Content Uniformity Testing.
abstract: The present research project involves development and validation of a stability-indicating HPTLC method for the estimation of naratriptan-HCl in their pharmaceutical dosage forms and its content uniformity testing. Naratriptan-HCl was subjected to alkaline, acidic, oxidative, neutral, thermal (dry heat) and photo-degradation conditions. The chromatographic separation was carried out using a precoated silica gel G 60 F254 TLC plate as the stationary phase and dichloromethane-toluene-methanol-triethylamine (4 : 4 : 2 : 1, v/v/v/v) as the mobile phase. The spots of NRT-HCl and its degradation products were detected at 290 nm. The Rf value of NRT-HCl was found to be 0.60 ± 0.02. The linearity was obtained in the range of 100-500 ng/spot. The limit of detection and limit of quantitation were found to be 6.07 ng/spot and 18.41 ng/spot, respectively. The percentage recovery was found in the range of 98.87-99.55%. NRT-HCl was degraded under acidic, alkaline and oxidative conditions while stable under photolytic, neutral and dry heat conditions. The developed method was applied for estimation of naratriptan-HCl in marketed formulations and its content uniformity testing.
authors.affiliation: Maliba Pharmacy College, Bardoli - Mahuva Road, Tarsadi 394350, Gujarat, India pintu.prajapati@utu.ac.in.
authors.forename: Pintu B
authors.initials: PB
authors.lastname: Prajapati
authors.affiliation: Maliba Pharmacy College, Bardoli - Mahuva Road, Tarsadi 394350, Gujarat, India.
authors.forename: Jagdish
authors.initials: J
authors.lastname: Chotalia
authors.affiliation: Maliba Pharmacy College, Bardoli - Mahuva Road, Tarsadi 394350, Gujarat, India.
authors.forename: Kunjan B
authors.initials: KB
authors.lastname: Bodiwala
authors.affiliation: Maliba Pharmacy College, Bardoli - Mahuva Road, Tarsadi 394350, Gujarat, India.
authors.forename: Bhavin P
authors.initials: BP
authors.lastname: Marolia
authors.affiliation: Maliba Pharmacy College, Bardoli - Mahuva Road, Tarsadi 394350, Gujarat, India.
authors.forename: Shailesh A
authors.initials: SA
authors.lastname: Shah
mesh_terms: D002855:Chromatography, Thin Layer / Q000379:methods / Q000592:standards*; D004355:Drug Stability; D005021:Ethylamines; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D000432:Methanol; D008752:Methylene Chloride; D010084:Oxidation-Reduction; D010880:Piperidines / Q000302:isolation & purification*; D015203:Reproducibility of Results; D012997:Solvents; D013607:Tablets / Q000032:analysis* / Q000737:chemistry; D014050:Toluene; D014363:Tryptamines / Q000302:isolation & purification*; D014662:Vasoconstrictor Agents / Q000302:isolation & purification*
chemical_list: D005021:Ethylamines; D010880:Piperidines; D012997:Solvents; D013607:Tablets; D014363:Tryptamines; D014662:Vasoconstrictor Agents; D014050:Toluene; D008752:Methylene Chloride; C106783:naratriptan; C016162:triethylamine; D000432:Methanol