scholarly journals Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

2017 ◽  
Vol 62 (2) ◽  
pp. 9-18 ◽  
Author(s):  
Kaitlin Nguyen ◽  
◽  
Danhui Zhang ◽  
Joseph Sherma ◽  
◽  
...  
Keyword(s):  
Pharmaceutical Products ◽  
Screening Methods ◽  
Potassium Clavulanate ◽  
Fluoxetine Hcl ◽  
Metformin Hcl ◽  
Model Approach

scholarly journals PVP-H2O2 Complex as a New Stressor for the Accelerated Oxidation Study of Pharmaceutical Solids

Pharmaceutics ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 457 ◽  
Author(s):  
Dattatray Modhave ◽  
Brenda Barrios ◽  
Amrit Paudel
Keyword(s):  
Hydrogen Peroxide ◽  
Solid State ◽  
Pharmaceutical Products ◽  
Screening Methods ◽  
Forced Degradation ◽  
Pharmaceutical Solids ◽  
Drug Degradation ◽  
Oxidation Study ◽  
Degradation Reactions ◽  
Forced Oxidation

Reactive impurities, such as hydrogen peroxide in excipients, raise a great concern over the chemical stability of pharmaceutical products. Traditional screening methods of spiking impurities into solid drug-excipient mixtures oversimplify the micro-environment and the physical state of such impurities in real dosage form. This can lead to an inaccurate prediction of the long-term product stability. This study presents the feasibility of using a polyvinylpyrrolidone-hydrogen peroxide complex (PVP-H2O2) as an oxidative agent for the solid state forced degradation of a selected drug, vortioxetine HBr. The PVP-H2O2 complex was prepared and characterized using FT-IR spectroscopy. The tablet compacts were made using a mixture of solid PVP-H2O2 complex and crystalline vortioxetine HBr powder. The compacts were exposed to 40 °C/75% RH condition in open and closed states for different time intervals. The extent and the type of drug degradation were analysed using LC and LC-MS. The extent of degradation was higher in the samples stored at the open state as compared to the close state. The solution state forced oxidation was conducted to verify the peroxide induced degradation reactions. The results evidence the utility of the proposed solid-state stressor and the method for screening the sensitivity of drugs to the excipient reactive impurities involving peroxides in solid-state.

scholarly journals An Innovative Method For Estimation Of Metformin HCl and Acarbose in Pharmaceutical Products and Seperation of Metformin Impurities By RP-HPLC

2020 ◽  
Vol 13 (2) ◽  
pp. 71-79
Author(s):  
Jalil K. Shaikh ◽  
Ajay Babu M ◽  
Mazahar Farooqui ◽  
Ummul Khair Asema Syed
Keyword(s):  
Diabetes Mellitus ◽  
Pharmaceutical Products ◽  
Dependent Diabetes Mellitus ◽  
Main Peak ◽  
Simultaneous Estimation ◽  
Combination Drug ◽  
Column Temperature ◽  
Related Impurities ◽  
Rp Hplc ◽  
Metformin Hcl

A Simple, rapid, cost effective, stability indicating RP-HPLC method has been developed for separation of Metformin HCl, its related impurities and Acarbose. Validated the method for simultaneous estimation of Metformin (MF) and Acarbose (ACB) in its novel combination of tablet formulation with Metformin 500 mg and Acarbose 50 mg. Metformin HCl is an orally-administered biguanide, anti-hyperglycemic agent, used in the management of non-insulin dependent diabetes mellitus. Acarbose is an oligosaccharide, used orally for the treatment of type 2 diabetes mellitus. The separation was achieved by using isocratic mobile phase consisting of mixture of phosphate buffer : acetonitrile (27:73 v/v), using Hypersil APS- 2 column, (250 x 4.6 mm x 5m) column at flow rate 2.0 mL/min. The detection was carried out at 210 nm with 20 μl of injection volume. The column temperature was maintained at 35 °C. The retention time (RT) of MF, its related impurities and ACB were found to be RT 2.6 min for 1-Cynogaunidine (RC A), 6.0 for Metformin (MF), 8.5 for 1-Methylbigaunidine (RC B), 10.4 for N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine(RC C), and 12.2 min for Acarbose (ACB). The approach was found to be linear with the concentration of 5-25 μg/ml and 2.5- 15μg/ml and correlation coefficient was 0.999 for MF and ACB respectively. The assay of estimated compounds was found to be 99.19% and 99.08% w/v and mean accuracy 100.66%, 101.59% for MF and ACB respectively. The developed method was validated as per ICH guidelines. The degradation products were well resolved from main peak. The validation was performed for various parameters like specificity, linearity, precision, accuracy and robustness studies. The method was found to be capable for simultaneous quantification of Metformin and Acarbose in its combination drug.

scholarly journals Importance of a High Performing GC-MS Based Screening Method for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities

2021 ◽  
Vol 3 (1) ◽  
pp. 3-20
Author(s):  
Gyorgy Vas ◽  
Louis Fleck ◽  
Anna Michelson ◽  
Nicole Dunn ◽  
John Duett ◽  
...  
Keyword(s):  
High Performance ◽  
Screening Method ◽  
Correlation Study ◽  
Pharmaceutical Products ◽  
Screening Methods ◽  
Mass Detection ◽  
Trace Level ◽  
High Performing ◽  
Targeted Screening ◽  
High Level

Leachable testing for finished pharmaceutical products is an important part of the regulatory filing and is under more regulatory scrutiny than ever before. Leachable testing for multiple finished drug products such as biologics, large volume parenterals, and polymer-based finished products requires analysis at trace levels with a high level of confidence. A high level of analytical expertise and top-of-the-line analytical instrumentation is required for work at trace levels. (The definition of trace level analytical testing has not been accurately defined; however, to have a sense of the “trace-level”-associated testing issues, we are arbitrarily assigning levels below 100 ng/mL as trace level and below 1 ng/mL as ultra-trace level in this paper). Leachable testing ideally should be performed on a targeted list of analytes compiled from an extractable study and an extractable and leachable correlation study, along with a general non-targeted screening evaluation to avoid any undetected leachables. For targeted screening, analytical testing is more straightforward and can typically detect targets at ppb or sub-ppb levels without issue. However, for a general screening method, this can be difficult, and many times requires special sample preparation combined with high-resolution accurate-mass detection. Case studies will be presented to demonstrate the importance of high-performance and highly sensitive screening methods in detecting unexpected leachables, and in supporting related quality investigations. The importance of well-designed and executed system suitability will also be discussed in this paper.

scholarly journals A REVIEW ON OPTIMIZATION OF DRUG DELIVERY SYSTEM WITH EXPERIMENTAL DESIGNS

2018 ◽  
Vol 10 (2) ◽  
pp. 7 ◽  
Author(s):  
Nazia Khanam ◽  
Md Irshad Alam ◽  
Quazi Md Aamer Iqbal Md Yusuf Ali ◽  
Aquil-ur-rahman Siddiqui
Keyword(s):  
Factorial Design ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Review Article ◽  
Optimization Techniques ◽  
Fractional Factorial ◽  
Experimental Designs ◽  
Present Review ◽  
Screening Methods ◽  
Pharmaceutical Industries

The present review article aims at determining the various possible techniques available to enhance the quality, safety and efficacy of pharmaceutical formulations by exploring most suitable and practically applicable experimental designs and optimization techniques. As we know that pharmaceutical industries are constantly in search of novel ideas to improve quality by various optimization techniques, hence in present review article we shall discuss latest optimization techniques and experimental designs to achieve the best combination of product and process characteristics under the given set of conditions. Experimental designs and optimization techniques are the tools that are simultaneously and systematically used to identify various types of problems that may influence research, development and production of pharmaceutical formulations. These are organized an approach to determine the relationship between the factors affecting a process and the output of that process. The screening methods discussed here include factorial design, fractional factorial designs, full factorial design, mixture designs etc. Recently, different software has been used in implementing optimization techniques in pharmaceutical products to enhance product quality by using most suitable available facilities.

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