Stress Degradation Studies on Tadalafil and Development of a Validated Stability-Indicating LC Assay for Bulk Drug and Pharmaceutical Dosage Form

2007 ◽  
Vol 67 (1-2) ◽  
pp. 183-188 ◽  
Author(s):  
D. V. Subba Rao ◽  
P. Radhakrishnanand ◽  
V. Himabindu
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Stress Degradation ◽  
Degradation Studies ◽  
Bulk Drug

scholarly journals STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD

2012 ◽  
Vol 57 (3) ◽  
pp. 1272-1276 ◽  
Author(s):  
V. K AHIRRAO ◽  
C. S PATIL ◽  
S. R BEMBALKAR ◽  
M. V KATARIYA ◽  
V. S SONNEKAR ◽  
...  
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Stress Degradation ◽  
Degradation Studies

Stability Indicating HPTLC Determination of Linezolid as Bulk Drug and in Pharmaceutical Dosage Form

2003 ◽  
Vol 29 (10) ◽  
pp. 1119-1126 ◽  
Author(s):  
Himani Agrawal ◽  
K. R. Mahadik ◽  
A. R. Paradkar ◽  
Neeraj Kaul
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Bulk Drug

scholarly journals Stability-Indicating High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Emtricitabine in Bulk Drug and Pharmaceutical Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Atul S. Rathore ◽  
Lohidasan Sathiyanarayanan ◽  
Kakasaheb R. Mahadik
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Linear Regression Analysis ◽  
Solvent System ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Bulk Drug

A simple, sensitive, precise, specific and stability indicating high-performance thin-layer chromatographic (HPTLC) method for the determination of emtricitabine both in bulk drug and pharmaceutical dosage form was developed and validated. The method employed aluminium plates precoated with silica gel G60 F254 as the stationary phase. The solvent system consisted of toluene : ethyl acetate : methanol (2 : 8 : 1, v/v/v). This solvent system was found to give compact spots for emtricitabine with value . Densitometric analysis of emtricitabine was carried out in the absorbance mode at 284 nm. Linear regression analysis showed good linearity with respect to peak area in the concentration range of 30–110 ng spot−1. The method was validated for precision, limit of detection (LOD), limit of quantitation (LOQ), robustness, accuracy and specificity. Emtricitabine was subjected to acid and alkali hydrolysis, oxidation, neutral hydrolysis, photodegradation and dry heat treatment. Also the degraded products peaks were well resolved from the pure drug with significantly different values. Statistical analysis proved that the method is repeatable and specific for the estimation of the said drug. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

scholarly journals NEW STABILITY-INDICATING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB MESYLATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 140
Author(s):  
Jahnavi Bandla ◽  
S. Ganapaty
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Ultra Performance Liquid Chromatography ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Relative Standard ◽  
Validation Parameters ◽  
Bulk Drug

Objective: The objective of the present study was to develop and validate a new stability-indicating method for the quantification of lenvatinib mesylate in bulk drug and pharmaceutical dosage form using ultra performance liquid chromatography (UPLC).Methods: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm × 2.1 mm, 1.8 m) column, mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v%) mobile phase run on an isocratic mode at a flow rate of 0.3 mL/min, 240 nm detection wavelength, and column oven temperature maintained at 30°C.Results: The retention time for lenvatinib was found to be 1.24 min. The developed method was validated for various validation parameters in accordance with the International Conference on Harmonization guidelines. The method obeyed Beer’s law in the concentration range of 2.5– 15 μg/mL with a correlation coefficient of 0.9996. The percentage relative standard deviation and percentage recovery were determined to be 0.4 and 99.66–100.30%, respectively. The developed method was found to be accurate, precise, specific, linear, rugged, and robust. Forced degradation studies were conducted by exposing the drug to diverse stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was obtained within the limits.Conclusion: The developed method for the estimation of lenvatinib can be employed to routine analysis of pharmaceutical dosage form.

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