Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Benidepine and Metoprolol by Strong Cation Exchange (SCX) Chromatography

2020 ◽  
Vol 11 (1) ◽  
pp. 06-12
Author(s):  
Koshish Babarao Gabhane ◽  
Dinesh Bhskarrao Kamdi ◽  
Chaitanya Arvind Gulhane ◽  
Pankaj Manohar Kharabe
Keyword(s):  
Cation Exchange ◽  
Simultaneous Estimation ◽  
Analytical Validation ◽  
Stability Indicating ◽  
Strong Cation Exchange

Simultaneous Estimation of Ilaprazole and Domperidone in Pharmaceutical Dosage Form

2016 ◽  
Vol 9 (6) ◽  
pp. 3549-3555
Author(s):  
Gopi Patel ◽  
Kiral M Prajapati ◽  
Bhavesh Prajapati ◽  
Samir K Shah
Keyword(s):  
Dosage Form ◽  
Ammonia Solution ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Linear Calibration ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Water Ph ◽  
Alkali Hydrolysis

A simple, accurate and precise stability-indicating RP-HPLC method was developed and subsequently validated for simultaneous determination of ilaprazole and domperidone in bulk and pharmaceutical dosage form. The proposed HPLC method utilizes  C18  (250 mm × 4.6 mm × 5 µm) column with mobile phase comprising of 0.5 % glacial acetic acid in water pH 5.5 adjusted with ammonia solution: methanol in the ratio 45:55 v/v at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 286 nm based on peak area with linear calibration curves at concentration  ranges 80-120µg/ml for ilaprazole and 240-360 µg/ml for domperidone  with correlation coefficient of 0.999.The retention times of ilaprazole and domperidone  were found to be 3.0 min, 5.4 min respectively. The mean recoveries obtained for ilaprazole and domperidone were found to be 99.76 ± 0.6463 % and 100.7 ± 0.2424 % respectively. Stress testing which covered acid, alkali hydrolysis, and peroxide, photolytic, thermal degradation was performed to prove the specificity of the proposed method and degradation was achieved. The proposed method was successfully applied for the stability indicating simultaneous estimation of ilaprazole and domperidone in routine quality control analysis in bulk and pharmaceutical formulation.

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.

Strong cation-exchange chromatography of proteins on a sulfoalkylated monolithic cryogel

2015 ◽  
Vol 1386 ◽  
pp. 13-21 ◽  
Author(s):  
Işık Perçin ◽  
Rushd Khalaf ◽  
Bastian Brand ◽  
Massimo Morbidelli ◽  
Orhan Gezici
Keyword(s):  
Cation Exchange ◽  
Exchange Chromatography ◽  
Cation Exchange Chromatography ◽  
Strong Cation Exchange ◽  
Strong Cation Exchange Chromatography

A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs

2021 ◽  
pp. 5443-5448
Author(s):  
Punna Venkateshwarlu ◽  
Mehul M. Patel
Keyword(s):  
Liquid Chromatography ◽  
Anticancer Drugs ◽  
Analytical Method ◽  
Analytical Methods ◽  
Bioanalytical Methods ◽  
Method Development ◽  
Estimation Methods ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating

This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.

DEVELOPMENT OF STABILITY INDICATING RP-HPLC-PDA METHOD FOR THE SIMULTANEOUS ANALYSIS OF NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 40-47
Author(s):  
B. N Nalluri ◽  
◽  
B. Mrudula ◽  
K Chitralatha ◽  
S. A Sultana ◽  
...  
Keyword(s):  
Naproxen Sodium ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Diphenhydramine Hydrochloride ◽  
Rp Hplc ◽  
The Stability ◽  
Tablet Dosage ◽  
Liquid Chromatographic

The present paper describes a sensitive and simple RP-HPLC-PDA method for the simultaneous estimation of Naproxen Sodium (NPX) and Diphenhydramine Hydrochloride (DPH) in the presence of their degradants. The drugs were subjected to stress conditions (forced degradation) to show the stability-indicating power of the method. The separation was achieved on Inertsil ODS C18 column (250×4.6mm, 5μ). The optimized liquid chromatographic conditions were found to be a mobile phase of 15mM ammonium acetate buffer: acetonitrile (60:40V/V) combination at a flow rate of 1.0 mL/min in isocratic mode with an injection volume of 10µL. The proposed method provided retention times of 4.6 and 10.8min, with linear responses over a range of 60-140μg/mL and 10-30μg/mL and regression coefficient (R2) of 0.999 and 0.996 respectively for NPX and DPH. No interference from other components of pharmaceutical dosage form and degradants was observed. The method was validated as per ICH guidelines and was successfully applied for the simultaneous estimation of both the drugs in bulk and tablet preparations.

Stability Indicating Assay Method Development and Validation of Simultaneous Estimation of Chlorzoxazone, Diclofenac Sodium and Paracetamol in Bulk Drug and Tablet by RP-HPLC

2021 ◽  
pp. 5024-5028
Author(s):  
Krutika Patel ◽  
Sudheer Kumar Verriboina ◽  
S.G. Vasantharaju
Keyword(s):  
Method Development ◽  
Diclofenac Sodium ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug

A simple, accurate, specific and stability-indicating RP-HPLC method was developed for simultaneous determination of chlorzoxazone, diclofenac sodium and paracetamol, using C18 Vydac Monomeric 120A (250 × 4.6mm, 5μ) at 40ºC. The mobile phase contains a mixture of 20mM potassium dihydrogen phosphate buffer (pH 6.2 adjusted with potassium hydroxide) and acetonitrile (30:70 v/v). The flow rate was 1ml/min and detection was carried out at 275nm using PDA detector. The retention time of paracetamol, chlorzoxazone and diclofenac sodium were 3.28mins, 13.27mins and 15.61mins respectively. The analytical curve was linear over a concentration range of 0.65- 6.5μg/ml for paracetamol, 1-10μg/ml for chlorzoxazone and 0.1-1μg/ml for diclofenac sodium. The drugs in bulk and tablet were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic degradation. This method can be successfully employed for simultaneous quantitative analysis of Chlorzoxazone, Diclofenac sodium and Paracetamol in bulk drug and tablet formulation.

scholarly journals SIMULTANEOUS ESTIMATION, VALIDATION, AND FORCED DEGRADATION STUDIES OF BETAHISTINE DIHYDROCHLORIDE AND DOMPERIDONE IN A PHARMACEUTICAL DOSAGE FORM USING RP-HPLC METHOD

2018 ◽  
Vol 11 (10) ◽  
pp. 125
Author(s):  
Vaishali Mistry ◽  
Rohan Mishra
Keyword(s):  
Hplc Method ◽  
Base Hydrolysis ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Betahistine Dihydrochloride ◽  
The Stability

Objective: This study describes the stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of betahistine dihydrochloride and domperidone in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic operation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 80:20% v/v and eluents were scanned using a UV detector at 244 nm.Results: The retention time of betahistine dihydrochloride and domperidone was found to be 2.3 and 3.6 min, respectively. A linearity response was observed in the concentration range of 9.6 μg/ml–22.4 μg/ml for betahistine dihydrochloride and 6–14 μg/ml for domperidone, respectively. Limit of detection and limit of quantification for betahistine dihydrochloride were 0.52 μg/ml and 1.58 μg/ml and for domperidone are 0.64 μg/ml and 1.94 μg/ml, respectively.Conclusion: The stability-indicating method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.

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