Impurity profile of macitentan in tablet dosage form using a stability-indicating high performance liquid chromatography method and forced degradation study

2019 ◽  
Vol 37 (1) ◽  
pp. 100
Author(s):  
S LAKKA Narasimha ◽  
KUPPAN Chandrasekar ◽  
RANGASAMY Parthasarathy
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Forced Degradation ◽  
Impurity Profile ◽  
Chromatography Method ◽  
Degradation Study ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

FORCED DEGRADATION STUDY OF ELETRIPTAN BY USING ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC)

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (07) ◽  
pp. 14-21
Author(s):  
S. Sahu ◽  
◽  
R.M Singh ◽  
S.C. Mathur ◽  
D. K Sharma ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Flow Rate ◽  
Mobile Phase ◽  
High Performance ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Degradation Study ◽  
Liquid Chromatography Method ◽  
Isocratic Mode

A simple, fast, precise and accurate ultra high performance liquid chromatography method was developed for degradation study of eletriptan hydrobromide (EH) under exaggerated conditions. An Inertsil ODS C18 (250 x 4.6 mm, 5µm) column in isocratic mode was used with mobile phase comprising of water, methanol and trifluoroacetic acid mixed in the ratio 55:45:0.1 % V/V/V, maintained at pH 3.5. The flow rate was set at 0.4 mL per minute with UV detection at 225 nm. The retention time of EH was found to be 3.7 minutes. Linearity for EH was found in the range of 3.5- 200 µg per mL and percentage recoveries were obtained in the range of 100.2 % to 100.6 %. The method was capable of resolving all degradants and principle component in sample. The proposed method is accurate, precise, selective, reproducible, and rapid for detection of degradation of eletriptan hydrobromide.

scholarly journals A SIMPLE REVERSE PHASE-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION OF VALSARTAN IN BULK AND IT’S TABLET DOSAGE FORM

2017 ◽  
Vol 10 (12) ◽  
pp. 333
Author(s):  
Ramreddy Godela ◽  
Sherisha Bhavani
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Quantitative Determination ◽  
High Performance ◽  
Dosage Form ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

Objective: The most important objective of the present research work is to develop simple, specific, rapid, accurate, and sensitive reverse-phase high-performance liquid chromatography method and validated for the qualitative and quantitative determination of valsartan in its active pharmaceutical ingredient and tablet dosage form according to ICH guidelines.Proposed Method: An isocratic separation was done using Phenomenex C18 column possess 75×4.6 mm, 2.6 μ,100 A0 dimensions with mobile phase composition of water:acetonitrile (30:70% v/v) by maintaining 1 ml/minute flow rate and response detected at a wavelength of 247 nm.Results: The retention time of valsartan was found to be 2.71 minutes, limit of detection and limit of quantification were observed at 1.24 μg/ml and 3.6 μg/ml concentration, respectively, and a calibration curve was linear in the concentration range of 5-50 μg/ml with coefficient of correlation 0.99. The percentage recovery (accuracy) was in the range of 98.9-102%, and the % relative standard deviation was observed to be <2%.Conclusion: The proposed method was validated for accuracy, precision, sensitivity, linearity, and robustness and successfully employed for the quantitative determination of valsartan in tablet dosage form in quality control department of pharmaceutical industry.

scholarly journals Development and Validation of High Performance Liquid Chromatography Method for Simultaneous Estimation of Ambroxol and Doxofylline in Their Combined Tablet Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-7
Author(s):  
Neha Singhal ◽  
Kalpesh Gaur ◽  
Anoop Singh ◽  
Karni Singh Sekhawat
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

The present study described a new, simple, accurate, and precise high performance liquid chromatography method for the simultaneous determination of Ambroxol and Doxofylline in combined tablet dosage form. The chromatographic method was standardized using a BDS hypersil C18, 250 mm × 4.6 mm, 5 μ (particle size), Thermo scientific from Germany with isocratic conditions, and mobile phase containing potassium dihydrogen orthophosphate buffer-pH 4.5 (0.05 M KH2PO4): acetonitrile (60 : 40) at flow rate of 1 ml/min using UV detection at 254 nm. The retention times of Ambroxol and Doxofylline were 3.510 min and 7.247 min, respectively. The method was linear over the concentration range for Ambroxol 3.75–11.25 μg/mL and for Doxofylline 50-150 μg/mL. The recovery of Ambroxol and Doxofylline was found to be in the range of 99.42–101.18% and 99.37–100.28%, respectively. The validation of method was carried out using ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.

scholarly journals Development and Validation of Stability-Indicating Reverse Phase-High Performance Liquid Chromatography Method for Simultaneous Determination of Atenolol and Nifedipine in Bulk and Tablet Dosage Form

2020 ◽  
Vol 11 (02) ◽  
pp. 219-223
Author(s):  
Ansari Yaasir Ahmed ◽  
Qazi Shoeb ◽  
Umme Rumana ◽  
Patel Afroza ◽  
Pathan Vahid Tajkhan ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Limit Of Quantitation

The new stability-indicating high performance liquid chromatography (HPLC) method has been developed and validated with different parameters for atenolol (ATE) and nifedipine (NIFE) in the combined dosage form. The chromatographic conditions were optimized using a mobile phase of MeOH:OPA (70:30) with a flow rate of 0.7 mL/min. Column (C18) of 4.6 × 250 mm dimension was used as a stationary phase; the particle size capacity of the column was 5 μm. The detection was carried out at 233 nm. The method was validated according to ICH guidelines for linearity, precision, repeatability, the limit of detection (LoD), and limit of quantitation (LoQ). The response was found to be linear in the concentration range of 20 to 100 mcg/mL for ATE and 1 to 5 mcg/mL for NIFE. The developed method shows the minimum quantity of drugs to be identified (LoD) and minimum drug to be quantified (LoQ). The LoD and LoQ were found to be 0.1415 and 0.4289, respectively, for ATE, and 0.1834 and 0.5558, respectively, for NIFE. The method was linear, simple, precise, and accurate and, therefore, suitable for routine analysis of drugs in tablet form. The forced degradation studies were also done through the exposure of analyte solution to four different stress conditions.

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