scholarly journals Validated Stability Indicating HPTLC Method for the Determination of Dutasteride in Pharmaceutical Dosage Forms

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Dipti B. Patel ◽  
Natubhai J. Patel ◽  
Sejal K. Patel ◽  
Paresh U. Patel
Keyword(s):  
Thin Layer ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Solvent System ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Wet Heat ◽  
Pure Drug

This paper describes simple, sensitive, precise, specific, and stability-indicating high-performance thin-layer chromatographic method for the determination of dutasteride (DUTA) in bulk and tablet formulation. Validation was carried out in compliance with International Conference on Harmonization guidelines. The thin-layer chromatographic method employed aluminium plates precoated with silica gel G60F254 as stationary phase. The solvent system consisted of toluene/methanol/triethylamine (9 : 2 : 1, v/v/v). This solvent system was found to give compact spots for dutasteride with value 0.71 ± 0.01. Densitometric analysis of DUTA was carried out in the absorbance mode at 274 nm. Linear regression analysis showed good linearity () with respect to peak area in the concentration range of 200–3000 ng per spot. The method was validated for precision, accuracy, specificity, and robustness. Pure drug was subjected to acid and alkali hydrolysis, oxidation, photo degradation, dry heat and wet heat treatment. The drug underwent degradation under acidic, basic, oxidative, and wet heat conditions. The degraded products were well separated from the pure drug. Statistical analysis proved that the method is reproducible and selective for estimation of DUTA in bulk and tablets. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

scholarly journals Application of a Stability-Indicating Thin-Layer Chromatographic Method to the Determination of Tenatoprazole in Pharmaceutical Dosage Forms

2009 ◽  
Vol 92 (2) ◽  
pp. 387-393 ◽  
Author(s):  
Sunil R Dhaneshwar ◽  
Vidhya K Bhusari ◽  
Mahadeo V Mahadik ◽  
B Santakumari
Keyword(s):  
Thin Layer ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
Stability Indicating ◽  
Limit Of Quantitation

Abstract A sensitive, selective, precise, and stability-indicating thin-layer chromatographic (TLC) method was developed and validated for the determination of tenatoprazole both as a bulk drug and in formulation. The method uses TLC aluminum plates precoated with Silica Gel 60F-254 as the stationary phase and the solvent system tolueneethyl acetatemethanol (6 4 1, v/v/v). This system gave compact spots for tenatoprazole (Rf value of 0.34 0.02). Tenatoprazole was subjected to acid and alkali hydrolysis, oxidation, and photodegradation. The peaks of the degradation products were well-resolved from that of the pure drug and had significantly different Rf values. Densitometric analysis of tenatoprazole was performed in the absorbance mode at 306 nm. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 1001500 ng/spot. The mean values of the correlation coefficient, slope, and intercept were 0.9989 1.42, 10.27 0.965, and 4894.2 1.24, respectively. The method was validated for precision, robustness, and recovery. The limit of detection and limit of quantitation were 50 and 100 ng/spot, respectively. Statistical analysis showed that the method is repeatable and selective for estimation of tenatoprazole. Because the method can separate the drug from its degradation products, it can be used to monitor stability.

VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR REPAGLINIDE API

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 48-54
Author(s):  
P. P. Thakkar ◽  
◽  
N. R Patel ◽  
C. S Kothari ◽  
R Patel ◽  
...  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Tablet Formulation ◽  
Content Uniformity ◽  
Calibration Data ◽  
Stability Indicating ◽  
Photolytic Degradation

A simple, precise and accurate stability-indicating high performance thin layer chromatographic method for estimation of repaglinide in bulk drug and in tablet formulation has been developed and validated. The stationary phase used was HPTLC plates precoated with silica gel 60F254 using the mobile phase of chloroform: methanol: ammonia (4.5:1.0:0.05 V/V/V). Densitometric analysis was performed in absorbance mode at 242 nm. The method showed compact bands of drug at RF value of 0.31 ± 0.02. Linear Regression analysis of calibration data showed good linear relationship with r2= 0.9981 in concentration range of 500 - 3000 ng/band. Drug was subjected to ICH-prescribed stress conditions such as acid, base, peroxide, thermal and photolytic degradation and method was found able to separate the peaks for all degradation products from analyte peak. Validation of the developed method was carried out for its specificity, linearity, range, precision, accuracy and robustness. The method was further applied for repaglinide estimation in pharmaceutical tablet formulation and it was found to be reliable. The method was also used successfully to carry out content uniformity test of repaglinide in tablet dosage form.

Stability-indicating thin-layer chromatographic method for determination of darunavir in complex darunavir–β-cyclodextrin in the presence of its degradation products

2014 ◽  
Vol 6 (11) ◽  
pp. 3689-3693 ◽  
Author(s):  
Ana Carolina Kogawa ◽  
Jaqueline Nakau Mendonça ◽  
Norberto Peporine Lopes ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Thin Layer ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Stability Indicating

A method was developed to identify degradation products of the complex darunavir–β-cyclodextrin.

A Versatile Stability-indicating Liquid Chromatographic Method for the Simultaneous Determination of Atenolol, Hydrochlorothiazide and Chlorthalidone

2020 ◽  
Vol 16 (8) ◽  
pp. 1037-1051
Author(s):  
Ehab Farouk Elkady ◽  
Marwa Ahmed Fouad ◽  
Abdulgabar A. Ezzy Faquih
Keyword(s):  
Quality Control ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Pharmaceutical Dosage Forms ◽  
Potassium Dihydrogen ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic ◽  
Potassium Dihydrogen Orthophosphate

Background: Atenolol is a selective beta 1 blocker that can be used alone or in combination with hydrochlorothiazide or with chlorthalidone for the treatment of hypertension and prevention from a heart attack. Objective: The main target of this work was to improve modern, easy, accurate and selective liquid chromatographic method (RP-HPLC) for the determination of these drugs in the presence of their degradation products. These methods can be used as analytical gadgets in quality control laboratories for a routine examination. Methods: In this method, the separation was accomplished through an Inertsil® ODS-3V C18 column (250 mm x 4.6 mm, 5 μm), the mobile phase used was 25 mM aqueous potassium dihydrogen orthophosphate solution adjusted to pH 6.8 by using 0.1M sodium hydroxide and acetonitrile (77 : 23, v/v), the flow rate used was 1 ml/min and detection was achieved at 235 nm using UV. Results: All peaks were sharp and well separated, the retention times were atenolol degradation (ATN Deg.) 2.311 min, atenolol (ATN) 2.580 min, hydrochlorothiazide degradation (HCT Deg.) 5.890 min, hydrochlorothiazide (HCT) 7.016 min, chlorthalidone degradation CTD Deg 8.018 min and chlorthalidone (CTD) 14.972 min. Linearity was obtained and the range of concentrations was 20- 160 μg/ml for atenolol, 10-80 μg/ml for hydrochlorothiazide and 10-80 μg/ml for chlorthalidone. According to ICH guidelines, method validation was accomplished, these methods include linearity, accuracy, selectivity, precision and robustness. Conclusion: The optimized method demonstrated to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

scholarly journals New Salting Out Stability-Indicating and Kinetic Thin Layer Chromatographic Method for Determination of Glimepiride and Metformin HCl Binary Mixture

2015 ◽  
Vol 53 (9) ◽  
pp. 1603-1610 ◽  
Author(s):  
Yahya Abduh Salim Mohamed ◽  
Abdel Maaboud Ismail Mohamed ◽  
Fardous Abdel-Fattah Mohamed ◽  
Sameh Abdel-Raouf Ahmed
Keyword(s):  
Binary Mixture ◽  
Thin Layer ◽  
Chromatographic Method ◽  
Salting Out ◽  
Stability Indicating ◽  
Metformin Hcl

scholarly journals Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Atomoxetine Hydrochloride in Tablets

2010 ◽  
Vol 93 (4) ◽  
pp. 1207-1214 ◽  
Author(s):  
Sejal K Patel ◽  
Natvarlal J Patel
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Stress Conditions ◽  
Acid Base ◽  
Photodiode Array Detection ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Wet Heat

Abstract This paper describes the development of a stability-indicating RP-HPLC method for the determination of atomoxetine hydrochloride (ATX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. In stability tests, the drug was susceptible to acid, base, oxidation, and dry and wet heat degradation. It was found to be stable under the photolytic conditions tested. The drug was successfully separated from the degradation products formed under stress conditions on a Phenomenex C18 column (250 4.6 mm id, 5 m particle size) by using acetonitrilemethanol0.032 M ammonium acetate (55 + 05 + 40, v/v/v) as the mobile phase at 1.0 mL/min and 40C. Photodiode array detection at 275 nm was used for quantitation after RP-HPLC over the concentration range of 0.55 g/mL with a mean recovery of 100.8 0.4 for ATX. Statistical analysis demonstrated that the method is repeatable, specific, and accurate for the estimation of ATX. Because the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.

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