Stability Studies of Active Ingredients and Preservatives in Dermatology Cream Using a Newly Developed and Validated RP-HPLC Method

2021 ◽  
Author(s):  
Awais Abbas ◽  
Sadaf Sarfraz ◽  
Umer Younas ◽  
Dr Muhammad Pervaiz Bhatti ◽  
Shahid Hussain ◽  
...  
Keyword(s):  
Hplc Method ◽  
Stability Studies ◽  
Active Ingredients ◽  
Rp Hplc

scholarly journals RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
Mohyeddin Assali ◽  
Murad Abualhasan ◽  
Nihal Zohud ◽  
Noura Ghazal
Keyword(s):  
High Performance ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Active Ingredients ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Relative Standard ◽  
Hplc Method Development

Background. Indomethacin is considered a potent nonsteroidal anti-inflammatory drug that could be combined with Paracetamol to have superior and synergist activity to manage pain and inflammation. To reduce the gastric side effect, they could be combined with Famotidine. Methodology. A codrug of Indomethacin and Paracetamol was synthesized and combined in solution with Famotidine. The quantification of the pharmaceutically active ingredients is pivotal in the development of pharmaceutical formulations. Therefore, a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated according to the International Council for Harmonization (ICH) Q2R1 guidelines. A reverse phase C18 column with a mobile phase acetonitrile: sodium acetate buffer 60 : 40 at a flow rate of 1.4 mL/min and pH 5 was utilized. Results. The developed method showed good separation of the four tested drugs with a linear range of 0.01–0.1 mg/mL (R2 > 0.99). The LODs for FAM, PAR, IND, and codrug were 3.076 × 10−9, 3.868 × 10−10, 1.066 × 10−9, and 4.402 × 10−9 mg/mL respectively. While the LOQs were 9.322 × 10−9, 1.172 × 10−10, 3.232 × 10−9, and 1.334 × 10−8 mg/mL, respectively. Furthermore, the method was precise, accurate, selective, and robust with values of relative standard deviation (RSD) less than 2%. Moreover, the developed method was applied to study the in vitro hydrolysis and conversion of codrug into Indomethacin and Paracetamol. Conclusion. The codrug of Indomethacin and Paracetamol was successfully synthesized for the first time. Moreover, the developed analytical method, to our knowledge, is the first of its kind to simultaneously quantify four solutions containing the following active ingredients of codrug, Indomethacin, Paracetamol, and Famotidine mixture with added pharmaceutical inactive ingredients in one HPLC run.

A Novel RP-HPLC Method for the Simultaneous Analysis of Some Active Ingredients in Cough-Cold Syrup Formulation

2017 ◽  
Vol 13 (3) ◽  
pp. 304-313 ◽  
Author(s):  
Sule Dinc Zor ◽  
Ozlem Aksu Donmez ◽  
Burge Asc| ◽  
Gizem Yarkadas
Keyword(s):  
Hplc Method ◽  
Simultaneous Analysis ◽  
Active Ingredients ◽  
Rp Hplc

Physical and chemical characterization of mefenamic acid in different pharmaceutical dosage forms and their stability studies using novel RP-HPLC method

2011 ◽  
Vol 21 (11) ◽  
pp. 3591-3597 ◽  
Author(s):  
Shabana Naz Shah ◽  
Agha Zeeshan Mirza ◽  
Hina Shamshad ◽  
Nighat Shafi ◽  
Malik Asia Naz
Keyword(s):  
Mefenamic Acid ◽  
Chemical Characterization ◽  
Dosage Forms ◽  
Hplc Method ◽  
Stability Studies ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Physical And Chemical Characterization ◽  
Physical And Chemical

scholarly journals RP-HPLC Method for the Simultaneous Determination of a Quaternary Mixture of Propyphenazone, Flavoxate HCl and Two of Their Official Impurities with Dissolution Profiling of Their Tablets

2020 ◽  
Vol 103 (4) ◽  
pp. 958-965
Author(s):  
Nariman A El-Ragehy ◽  
Nesrin K Ramadan ◽  
Mona T Ragab ◽  
Badr A El-Zeany
Keyword(s):  
Carboxylic Acid ◽  
Simultaneous Determination ◽  
The United States ◽  
Hplc Method ◽  
Active Ingredients ◽  
Rp Hplc ◽  
Quaternary Mixture ◽  
Flavoxate Hcl

Abstract Background Determination of different drugs in the presence of their impurities is now receiving attention from regulatory authorities such as the ICH and the United States Food and Drug Administration (USFDA). Objective To develop and validate a reversed-phase (RP)-HPLC method for the simultaneous separation and quantification of a quaternary mixture of propyphenazone, flavoxate HCl, and their official impurities; phenazone and 3-methylflavone-8-carboxylic acid, respectively. Then utilize the validated method as an in vitro methodology to monitor the rate of release of the active ingredients from Cistalgan® tablets. Methods RP-HPLC method was applied using Kinetex® coreshell C8 column (250 mm × 4.6 mm I.D., particle size 5 μm) and acetonitrile: phosphate buffer pH 3.50 (42:58, v/v) as the mobile phase with UV detection at 240.0 nm. Results The studied components were eluted with average retention times of 2.80, 3.40, 4.20, and 5.90 min for phenazone, flavoxate HCl, 3-methylflavone-8-carboxylic acid, and propyphenazone, respectively within linearity range of 1.00–60.00 µg/mL propyphenazone, 3.00–60.00 µg/mL flavoxate HCl and 0.50–40.00 µg/mL of the specified impurities. Conclusions The suggested method could be considered as the first validated analytical method for the simultaneous determination of the studied components and proved to be accurate, precise, sensitive, and robust. Highlights The proposed method displays a useful analytical tool for dissolution profiling and clear discrimination of both active ingredients from their impurities along with impurities profiling.

scholarly journals BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TICAGRELOR BY RP-HPLC

2017 ◽  
Vol 9 (3) ◽  
pp. 51 ◽  
Author(s):  
Delma D’cruz ◽  
Anu Babu ◽  
Eena Joshy
Keyword(s):  
Human Plasma ◽  
Method Development ◽  
Hplc Method ◽  
Array Detector ◽  
Stability Studies ◽  
Short Term ◽  
Term Stability ◽  
Long Term Stability ◽  
Rp Hplc

Objective: The main purpose of this study was to develop a simple, precise, rapid and accurate RP-HPLC method for the quantitative determination of ticagrelor in human plasma. Methods: The separation was accomplished by the isocratic method by utilizing phenomenex C18 column on a Shimadzu binary gradient liquid chromatography system furnished with LC-20AD solvent delivery system, SPD-20-A photo-diode array detector and 20 µl loop volume in a rheodyne injector. The analyte was extracted by protein precipitation in the involvement of diethyl ether as a protein precipitator. The mobile phase was developed for the estimation of the drug in human plasma consists of acetonitrile and methanol in the ratio of 60:40% v/v. Separation was done with a flow rate of 1 ml/min at a detection wavelength of 254 nm.Results: Retention time was found to be 4.503 min with a run time 10 min. Linearity shows in a range of 20-100 µg/ml, with a correlation coefficient of 0.9992 respectively. Stability studies of ticagrelor in plasma were carried out by, short term stability, long term stability and bench top stability studies. Short term stability, long term stability and bench top stability of ticagrelor was carried out from 20 and 100 µg/ml concentration and %RSD was ascertained 0.12% and 0.08%, 0.18% and 0.15%, 1.19% and 1.30% respectively.Conclusion: The outcomes were observed to be inside the knowledge of ICH guidelines. The prepared solution was injected in triplicate, and % RSD was measured. Acquired results demonstrate that proposed strategy can be effortlessly and advantageously applied for routine examination of ticagrelor in human plasma

scholarly journals Stress Degradation Studies on Bimatoprost and Development of Validated Stability Indicating Densitometric RP-TLC and HPLC Methods

2019 ◽  
pp. 5-10
Author(s):  
Maha M Abou El-Alamin ◽  
Safaa Toubar ◽  
Maha A Elabd ◽  
Nahla N Salama ◽  
Mohammed Walash
Keyword(s):  
Degradation Products ◽  
Research Work ◽  
Oxidative Degradation ◽  
Ophthalmic Solution ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Studies ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Stress Degradation

Simple, sensitive and accurate stability-indicating densitometric RP-TLC and RP HPLC-UV methods were developed and validated for analysis of Bimatoprost (BMT). Stress stability studies were performed using hydrolytic (acid & alkai) and oxidative degradation products and conformed using LC-MS. Structure elucidation and pathway of degradation were presented. Both methods were based on reversed phase thin-layer and liquid chromatographic separation of BMT from hydrolytic and oxidative degradation products. Acetonitrile, water and 33% ammonia (4:5:1, by volume) and acetonitrile –water (40:60, v/v) at 30◦C were used as mobile phases for separation of BMT from degradation products using RP TLC and HPLC methods respectively. Quantification was achieved at 220 nm for both methods. The linear ranges were 0.5-6.0 μg/band and 5 – 100 μg /mL with mean recoveries ± RSD%, of 98.72 ± 0. 31% and 99.25 ± 0.59% for the two methods respectively. The specificity of HPLC method was further assured by peak purity. The proposed methods are rapid with retention time less than 6 min. The methods met ICH regulatory requirements. The two methods were successfully applied for the quantification of BMT in drug substance and ophthalmic solution with acceptable accuracy and precisions; the label claim percentages were 93.145 ± 0.89 and 95.35 + 0.65 for densitometric RP-TLC and RP HPLC-UV methods respectively. The research work has a great value for quality control and stability studies of BMT.

scholarly journals A Rapid, Isocratic HPLC Method for Determination of Insulin and Its Degradation Product

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Najjar ◽  
Mahmoud Alawi ◽  
Najiah AbuHeshmeh ◽  
Alsayed Sallam
Keyword(s):  
Linear Response ◽  
Internal Standard ◽  
Hplc Method ◽  
Stability Studies ◽  
Rp Hplc ◽  
Column Type ◽  
Chromatographic Procedure ◽  
Main Decomposition ◽  
Isocratic Hplc

This paper aimed to develop a simple, sensitive, and rapid chromatographic procedure for the simultaneous analysis of human insulin and its main decomposition product using isocratic RP-HPLC/UV. A column type RP-C18 (100 × 4.6 mm, 3 μm particle size, and pore size 130 Å) was used. o-Nitrophenol was used as internal standard. The eluent consists of 62% KH2PO4 buffer (0.1 M), 26% ACN, and 12% MeOH. The final pH was adjusted to 3.1. The eluent was pumped at a flow rate of 1.0 mL/min and the effluent was monitored using DAD detector at 214 nm. The method produces a linear response over the concentration range of 0.0106 to 0.6810 mg/mL with detection limit of 0.0029 mg/mL. Considering the specifications of this method, the system was found to be suitable for rapid, direct routine analysis and stability studies of insulin.

scholarly journals Development and Validation of an Isocratic, Sensitive and Facile RP-HPLC Method for Rapid Analysis of 5-Fluorouracil and Stability Studies Under Various Stress Conditions

2013 ◽  
Vol 25 (13) ◽  
pp. 7177-7182 ◽  
Author(s):  
Nazrul Haq ◽  
Faiyaz Shakeel ◽  
Fars K. Alanazi ◽  
Awwad A. Radwan ◽  
Mohammad Ali ◽  
...  
Keyword(s):  
Hplc Method ◽  
Rapid Analysis ◽  
Stress Conditions ◽  
Stability Studies ◽  
Rp Hplc ◽  
Development And Validation

scholarly journals Simultaneous RP-HPLC determination of sparfloxacin and dexamethasone in pharmaceutical formulations

2013 ◽  
Vol 49 (2) ◽  
pp. 301-309 ◽  
Author(s):  
Syed Naeem Razzaq ◽  
Muhammad Ashfaq ◽  
Irfana Mariam ◽  
Islam Ullah Khan ◽  
Syed Saleem Razzaq
Keyword(s):  
Degradation Products ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Array Detector ◽  
Diode Array ◽  
Stability Studies ◽  
Diode Array Detector ◽  
Rp Hplc ◽  
Peak Purity

The present study describes the development and subsequent validation of simple and accurate stability indicating RP-HPLC method for the determination of sparfloxacin and dexamethasone in pharmaceutical formulations in the presence of their stress-induced degradation products. Both the drugs and their stress-induced degradation products were separated within 10 minutes using C8 column and mixture of methanol and 0.02 M phosphate buffer pH 3.0 (60:40 v/v, respectively) as mobile phase at 270 nm using diode array detector. Regression analysis showed linearity in the range of 15-105 µg/mL for sparfloxacin and 5-35 µg/mL for dexamethasone. All the analytes were adequately resolved with acceptable tailing. Peak purity of the two drugs was also greater than 0.9999, showing no co-elution peaks. The developed method was applied for simultaneous determination of sparfloxacin and dexamethasone in pharmaceutical formulations for stability studies.

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