scholarly journals Stability-Indicating RP-HPLC Method Development and Validation for Duloxetine Hydrochloride in Tablets

2010 ◽  
Vol 93 (1) ◽  
pp. 123-132 ◽  
Author(s):  
Sejal K Patel ◽  
Natavarlal J Patel ◽  
Arun M Prajapati ◽  
Dipti B Patel ◽  
Satish A Patel
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Hplc Method ◽  
Stress Conditions ◽  
Photodiode Array Detection ◽  
Heat Condition ◽  
Stability Indicating ◽  
Dry Heat ◽  
Duloxetine Hydrochloride ◽  
Rp Hplc

Abstract This paper describes the development of a stability-indicating RP-HPLC method for duloxetine hydrochloride (DLX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. The drug was found to be stable to the dry heat condition attempted. Successful separation of the drug from the degradation products formed under stress conditions was achieved on a Phenomenex C18 column (250 4.6 mm id, 5 µm particle size) using acetonitrilemethanol0.032 M ammonium acetate buffer (55 + 05 + 40, v/v/v) as the mobile phase at a flow rate of 1.0 mL/min at 40°C temperature. Quantification was achieved with photodiode array detection at 290 nm over the concentration range 0.25 µg/mL with mean recovery of 101.048 ± 0.53 for DLX by the RP-HPLC method. Statistical analysis proved the method is repeatable, specific, and accurate for estimation of DLX. Because the method could effectively separate the drug from its degradation products, it can be used as a stability-indicating method.

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.

scholarly journals Stability-Indicating RP-HPLC Method for Assay of Silver Lactate

2011 ◽  
Vol 8 (2) ◽  
pp. 483-490
Author(s):  
V. Srinivasan ◽  
H. Sivaramakrishnan ◽  
B. Karthikeyan
Keyword(s):  
Thermal Stress ◽  
Degradation Products ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Stress Conditions ◽  
Base Hydrolysis ◽  
Assay Method ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc

A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products formed under stress conditions was achieved on a phenomenex Gemini column with potassium dihydrogen phosphate buffer, pH adjusted to 2.2 with orthophosphoric acid, as mobile phase. The method was validated for linearity, precision, specificity and robustness and can be used for quality-control during manufacture and assessment of the stability of samples of silver lactate. To the best of our knowledge, a validated stability-indicating LC assay method for silver lactate based on lactic acid is reported for the first time.

RP-HPLC METHOD FOR DETERMINATION OF TOLPERISONE HYDROCHLORIDE IN TABLET FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 48-53
Author(s):  
S. P Padmane ◽  
◽  
A. A Thakur ◽  
R. N. Alaspure ◽  
M. R. Tajne
Keyword(s):  
Oxidative Stress ◽  
Degradation Products ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Stress Conditions ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Effluent Flow Rate ◽  
And Oxidative Stress

The study describes a validated stability indicating reverse-phase HPLC method for the estimation of tolperisone in bulk and in tablet formulation. The proposed RP-HPLC method utilizes a Hypersil C18 column (250 × 4.6 mm, 5 μm), optimum mobile phase consisted of methanol: acetonitrile: water (containing triethylamine 1% V/V) in the ratio of (85:10:5 V/V/V), effluent flow rate was kept at 1.0 mL/min and UV detection wavelength 250 nm. Tolperisone was exposed to various hydrolytic, thermal, photolytic and oxidative stress conditions, and the stressed samples were analysed by proposed method. The drug showed degradation under alkali and neutral hydrolysis and oxidative stress conditions. The degradation products were well resolved from the drug and demonstrated that the method is specific stability indicating for assay of tolperisone in presence of degradation products. The developed method was validated for linearity, accuracy, precision, robustness, ruggedness and specificity.

scholarly journals Application of Response Surface Methodology in Development and Optimization of Stability Indicating RP-HPLC Method for Determination of Tolvaptan in Bulk and Formulation

2021 ◽  
pp. 137-148
Author(s):  
A. S. Sutar ◽  
C. S. Magdum
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Design Of Experiment ◽  
Mobile Phase ◽  
Method Development ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Indicating ◽  
Rp Hplc

Design of Experiment assisted stability indicating RP-HPLC was developed and optimized using response surface methodology for determination of Tolvaptan.  Mobile phase was developed and optimized using Design of Experiment with response surface methodology. Acetonitrile and phosphate buffer with pH 5.5 (70:30% V/V) was optimized as mobile phase. The flow rate was maintained at 1ml/min. Stress studies were performed as per guidelines. Method was validated in accordance with regulatory requirements and results were within specified limits of regulatory guidelines. Tolvaptan was eluted at 3.24 min. It shows linearity from 2.5-15 µg/ml. Coefficient of correlation was 0.999, LOD and LOQ values were 1.0871 (µg/ml) and 3.2942 (µg/ml). Precision was determined with % RSD of 0.8669 and 0.9709%, mean percentage Recovery value was found to be 99.88 ±1.2. All stress degradation products are very well resolved from drug peak which indicate suitability indicating nature of the developed method. Design of Experiment technique can help in fast and economical optimization of mobile phase which inturn will save time for method development. The developed method is simple, accurate, sensitive which can be utilised as stability indicating method for identification of degradation products in routine analysis of the drug.

scholarly journals Stability Indicating Analytical Method Development and Validation for the Estimation of Rimegepant in Bulk and Its Tablets Using Rp-HPLC

2021 ◽  
pp. 41-49
Author(s):  
H. M. Sudheer Kumar ◽  
Kothapalli Bannoth Chandrasekhar
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Hplc Method ◽  
Cgrp Receptor ◽  
Stability Indicating ◽  
Pharmaceutical Ingredients ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Cgrp Receptor Antagonist ◽  
Development And Validation

Aim: Ramegepant is a novel molecule belongs to the class of calcitonin gene – related peptide (CGRP) receptor antagonist, which was developed for the prevention and treatment of migraine. Ramegepant was reported to act at the CGRP receptor with good oral bioavailability. The objective of this study was to develop a simple and fast stability indicating method for the determination of Ramegepant in bulk and tablets. Methodology: Ramegepant was eluted on a Waters C18 Column with 250 mm × 4.6 mm i.d and 5 μm Particle size with a mobile phase of Potassium dihydrogen orthophosphate buffer pH 7.0 : Methanol 30:70 v/v in isocratic mode at a flow rate of 0.8 ml/min. The analyte was quantified using a 272 nm PDA detector. Results: The chromatograms of Ramegepant obtained with this method showed a well resolved retention time at 3.29 min of its excipients and degradation products. The area of ​​the peak with respect to the concentration calibration curves, which were linear from 70 to 210 µg / ml, had a regression coefficient (r2) greater than 0.999. Accuracy and precision have been determined and perfectly matched to the ICH standards. Conclusion: The study showed that the proposed Rp-HPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.

scholarly journals Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Codeine Phosphate and Chlorpheniramine Maleate from Their Combined Liquid Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Ramakrishna Kommana ◽  
Praveen Basappa
Keyword(s):  
Limit Of Detection ◽  
Degradation Products ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Codeine Phosphate ◽  
Chlorpheniramine Maleate ◽  
Combination Drug ◽  
Stability Indicating ◽  
Rp Hplc

The present paper describes the development of quick stability indicating RP-HPLC method for the simultaneous estimation of codeine phosphate and chlorpheniramine maleate in the presence of its degradation products, generated from forced degradation studies. The developed method separates codeine phosphate and chlorpheniramine maleate in impurities/degradation products. Codeine phosphate and chlorpheniramine maleate and their combination drug product were exposed to acid, base, oxidation, dry heat, and photolytic stress conditions, and the stressed samples were analysed by proposed method. The proposed HPLC method utilizes the Shimadzu HPLC system on a Phenomenex C18 column (, 5 μ) using a mixture of 1% o-phosphoric acid in water : acetonitrile : methanol (78 : 10 : 12) mobile phase with pH adjusted to 3.0 in an isocratic elution mode at a flow rate of 1 mL/min, at 23°C with a load of 20 μL. The detection was carried out at 254 nm. The retention time of codeine phosphate and chlorpheniramine maleate was found to be around 3.47 min and 9.45 min, respectively. The method has been validated with respect to linearity, robustness, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The developed validated stability indicating HPLC method was found to be simple, accurate, and reproducible for the determination of instability of these drugs in bulk and commercial products.

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