scholarly journals Stability Indicating Method to Analyze Benidipine and Chlorthalidone Using HPLC Technique: Establishment, Validation and Application to Tablets

2020 ◽  
Vol 26 (1) ◽  
pp. 75-81
Author(s):  
Kadali Jagadeesh ◽  
Nowduri Annapurna
Keyword(s):  
Hplc Method ◽  
Phase System ◽  
Reverse Phase ◽  
Degradation Study ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Dipotassium Hydrogen Phosphate ◽  
Photodiode Array ◽  
Tablet Dosage

Background : The combination of chlorthalidone and benidipine was used to manage hypertension. The mixture of chlorthalidone and benidipine in tablet dosage form has not been previously determined by any method. A stability indicating HPLC method was developed for the simultaneous determination of benidipine and chlorthalidone in bulk and tablets. Methods: Chromatographic separation was accomplished in a reverse phase system using an isocratic elution with a mobile phase composed of methanol-0.1M dipotassium hydrogen phosphate buffer (40:60, v/v), at 1 ml/min flow rate. The photodiode array (PDA) detector set at 260 nm was used to detect and quantify benidipine and chlorthalidone. Benidipine and chlorthalidone tablet samples were subjected to degradation under acid, neutral, alkali, thermal, photo and oxidative. The proposed method was effectively adapted to quantify benidipine and chlorthalidone in the combined tablet formulation. Results: The elution times for benidipine and chlorthalidone were approximately 4.573 min and 6.422 min, respectively. The method was validated within a concentration range of 2 - 6 μg/ml (R2 = 0.9997) for benidipine and 6.25 - 18.75 μg/ml (R2 = 0.9998) for chlorthalidone. Adequate results were obtained for precision (RSD% = 0.106% for benidipine and RSD% = 0.031% for chlorthalidone) and accuracy (99.95 - 100.25 % mean recovery for benidipine and 99.60 - 99.63% mean recovery for chlorthalidone). Robustness has also been found to be acceptable. During the degradation study, interference was not noticed in the analysis of studied drugs. Conclusion: The findings demonstrated that the method could be useful for determination of the selected drug combination in routine analysis.

scholarly journals Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation

2013 ◽  
Vol 1 (04) ◽  
pp. 45-54 ◽  
Author(s):  
M. Krishna Chaitanya Prasad ◽  
G. Vidhya Sagar ◽  
P. Sudhakar
Keyword(s):  
Stress Testing ◽  
Hplc Method ◽  
Chromatographic Separations ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Photodiode Array ◽  
Standard Calibration ◽  
Tablet Dosage

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex_ C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm (_ max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation studies. The standard calibration curve was plotted for the drug and results showed that the drug was linear (r2 = 0.999) in the concentration range between 0.01 – 1.5 μg/ml. The results of stress testing undertaken according to the International Conference on Harmonization (ICH) guidelines reveal that the selected method is selective and stability-indicating for determination of levitiracetam in pharmaceutical formualtion.

Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination

2018 ◽  
Vol 42 (4) ◽  
pp. 2459-2466 ◽  
Author(s):  
N. Singh ◽  
P. Bansal ◽  
M. Maithani ◽  
Y. Chauhan
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Dose Combination ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

scholarly journals A new stability-indicating RP-HPLC method for the determination of dicyclomine hydrochloride and dimethicone combination in tablet dosage forms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy
Keyword(s):  
Liquid Chromatography ◽  
Dosage Forms ◽  
Flow Speed ◽  
Hplc Method ◽  
Stability Indicating ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Tablet Formulations ◽  
Tablet Dosage

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.

Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

2021 ◽  
pp. 4635-4639
Author(s):  
Ashok B. Patel ◽  
Ekta H. Vaghasiya ◽  
Amit R. Dudhatra ◽  
Amitkumar J. Vyas ◽  
Ajay I. Patel ◽  
...  
Keyword(s):  
Dosage Form ◽  
Active Pharmaceutical Ingredient ◽  
Array Detector ◽  
Column Temperature ◽  
Stability Indicating ◽  
Photodiode Array Detector ◽  
Acceptable Method ◽  
Photodiode Array ◽  
Tablet Dosage

Stability indicating RP-UPLC photo diode array detector based method for determination of Dapagliflozin propanediol monohydrate (DPM) in active pharmaceutical ingredient (API) and in tablet dosage form (5mg dapagliflozin) has been developed and validated on Bridge Ethylene Hybride (BEH) C18 column (50mm × 2.1 mm, 1.7µm). Mobile phase composition was water: acetonitrile (60:40 v/v), flow rate 0.5ml/min and detection carried out at 223nm at column temperature 30ºC. Chromatographic separation achieved within 2 min with retention time 0.77 min. Linearity of the method was found over the concentration range of 25-75µg/ml (R2 = 0.9977). The degradation was carried out in five different stress conditions. The developed method was able to resolve peak of API from all generated peaks. Sufficient degradation was achieved in the range of 5.25 to 12.31%. The peak purity is acceptable, Method validation was performed as per ICH guideline Q2(R1).

REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.

scholarly journals Validation of a Stability-Indicating RP-HPLC Method for the Determination of Entecavir in Tablet Dosage Form

2010 ◽  
Vol 93 (2) ◽  
pp. 523-530 ◽  
Author(s):  
Sérgio Luiz Dalmora ◽  
Maximiliano da Silva Sangoi ◽  
Daniele Rubert Nogueira ◽  
Lucélia Magalhães da Silva
Keyword(s):  
Dosage Form ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Forced Degradation ◽  
Photodiode Array Detection ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Tablet Dosage

Abstract An RP-HPLC method was validated for the determination of entecavir in tablet dosage form. The HPLC method was carried out on a Gemini C18 column (150 4.6 mm id) maintained at 30C. The mobile phase consisted of acetonitrilewater (95 + 5, v/v)/potassium phosphate buffer (0.01 M, pH 4; 9 + 91, v/v) pumped at a flow rate of 1.0 mL/min. Photodiode array detection was at 253 nm. The chromatographic separation was obtained with a retention time of 4.18 min, and the method was linear in the range of 0.5200 g/mL (r2 0.9998). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients and an increase of the cytotoxicity only by the basic condition. The accuracy was 101.19, with bias lower than 1.81. The LOD and LOQ were 0.39 and 0.5 g/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.

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.

Kinetic study of the alkaline degradation of imidapril hydrochloride using a validated stability indicating HPLC method

RSC Advances ◽  
2016 ◽  
Vol 6 (73) ◽  
pp. 69239-69250
Author(s):  
Shabaan A. Abdulla ◽  
Eman Y. Frag ◽  
Heba E. Ahmed
Keyword(s):  
Kinetic Study ◽  
Degradation Products ◽  
Hplc Method ◽  
Alkaline Degradation ◽  
Degradation Study ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Imidapril Hydrochloride

An aqueous alkaline degradation study was performed for imidapril hydrochloride (IMD) drug in the presence of its degradation products and an isocratic stability indicating method was presented using HPLC.

scholarly journals Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

2021 ◽  
Vol 104 (4) ◽  
pp. 57-68
Author(s):  
V.G. Kamani ◽  
◽  
M. Sujatha ◽  
G.B. Daddala ◽  
◽  
...  
Keyword(s):  
Ammonium Acetate ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Forced Degradation ◽  
Degradation Study ◽  
Stability Indicating ◽  
System Suitability ◽  
Development And Validation ◽  
First Time

This study reports for the first time about a stability indicating RP-HPLC method for analysis of darolutamide and its impurities 1, 2, and 3 in bulk and formulations. The separation was achieved on Phenomenex column with Luna C18 (250 mm × 4.6 mm, 5 μm) as stationary phase, and 50 mM ammonium acetate: methanol solution 15:80 (v/v) at pH 5.2 as mobile phase at 1.0 mL/min flow rate. UV detection was carried at wavelength of 239 nm. In these conditions the retention time of darolutamide and its impurities 1, 2, and 3 was 7.05, 8.90, 4.63 and 5.95 min, respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability, and robustness. Forced degradation study was done through exposure of the analyte to five different stress conditions and the % degradation was small in all degradation condition. The proposed method can separate and estimate the drug and its impurities in pharmaceutical formulations. Hence, the developed method was suitable for the quantification of darolutamide and can separate and analyse impurities 1, 2, and 3

scholarly journals Quantification of Pimavanserin in Bulk and Tablet Dosage Form Using A Stability Indicating High Performance Liquid Chromatographic Method

2018 ◽  
Vol 24 (4) ◽  
pp. 291-297 ◽  
Author(s):  
Geetha Bhavani Koduri ◽  
Hari Babu Bollikolla ◽  
Ramachandran Dittakavi ◽  
Srinivasu Navuluri
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Degradation Products ◽  
Antipsychotic Agent ◽  
Hplc Method ◽  
Array Detector ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Tablet Dosage

Background: Pimavanserin, an antipsychotic agent, is used to treat patients suffering with Parkinson's disease. Till now no stability indicating reverse phase HPLC method was reported for the quantification of pimavanserin in bulk and tablet dosage form. Hence in the present study, a new sensitive, precise and accurate stability indicating reverse phase HPLC method with photodiode array detector has been developed for the quantification of pimavanserin in bulk and tablet dosage form. Methods: Separation and analysis of pimavanserin was achieved on Kromasil C18 (5 µm, 250 mm × 4.6 mm) column using 0.1M NaH2PO4, methanol and acetonitrile in ratio of 55:30:15 (v/v/v) as mobile phase at 25°C. The flow rate was 1.0 ml/min. The effluents were monitored with detector set at 239 nm. The method validation was done with regard to the guidelines by the International Conference on Harmonization. Pimavanserin was subjected to acid, alkali and neutral hydrolysis, hydrogen peroxide oxidation, thermal degradation, and photo (sunlight) degradation. Results: Linear relationship was obtained between the concentration of drug and peak area response in the range of 4.25-34.0 µg/ml. The limits of detection and quantitation were found to be 0.027 µg/ml and 0.089 µg/ml, respectively. All the validation characteristics were within the acceptance criteria. The peaks of degradation products were well resolved from the pimavanserin peak. Conclusion: The developed and validated method is able to quantify the pimavanserin in the presence of degradation products.

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