A Literature Study of IPQC (In Process Quality Control) tests and FDF (Finished Dosage Form) tests for Parenteral Dosage forms taking Adicovil IV Ampoule as an Example.

2017 ◽  
Vol II (I) ◽  
pp. 44-55
Author(s):  
Ayesha Sabir ◽  
Syeda Komal Fatima ◽  
Asma Kaleem ◽  
Sidra Altaf ◽  
Imran Khan
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Small Volume ◽  
Volatile Matter ◽  
Process Quality ◽  
Type I ◽  
Literature Study ◽  
Physical Tests ◽  
Parenteral Product

This study was conducted to evaluate both the in-process quality control tests as well as the finished dosage form tests for a parenteral product. Furthermore, all the processes from the purchase of API to marketing of product were studied. A batch of Adicovil was taken Adicovil was taken as an example, it is small volume parenteral of 2ml ampoule that is studied to evaluate its efficacy and stability by performing chemical and physical tests. IPQC tests for type I glass includes powder glass test, while for water for injection they are pH, acidity & alkalinity, non-volatile matter, ammonium ions, non-oxidizable matter, sterility and pyrogen test. Test for finished dosage form of Adicovil are identification, leaker test, clarity test, sterility, pyrogen test, BET, deliverable volume and determination of volume of injection for container. The selected batch of Adicovil passed all the IPQC and FDF tests in the procedure.

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF LAMIVUDINE IN TABLET DOSAGE FORM

2017 ◽  
Vol 9 (6) ◽  
pp. 86
Author(s):  
Kalpesh V. Sonar ◽  
Prabodh Sapkale ◽  
Anil Jadhav ◽  
Tushar Deshmukh ◽  
Swapnil Patil ◽  
...  
Keyword(s):  
Quality Control ◽  
Absorption Spectrum ◽  
Melting Point ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Beer’S Law ◽  
Solubility Studies ◽  
Development And Validation ◽  
Tablet Dosage

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lamivudine in tablet dosage form.Methods: The drug is freely soluble in analytical grade water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed a good correlation of concentration with absorption which reflects in linearity. The UV spectroscopic method was developed for estimation of lamivudine in tablet dosage form and also validated as per ICH guidelines.Results: The drug is freely soluble in analytical grade water, slightly soluble in methanol and practically insoluble in acetone. So, the analytical grade water is used as a diluent in the method. The melting point of lamivudine was found to be 160-161˚C (uncorrected). It showed absorption maxima 268 nm in analytical grade water. On the basis of the absorption spectrum, the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of the analysis were validated by recovery studies. The recovery was found to be 98.7, 101 and 99.2% for three levels respectively. The % RSD for precision was found to be 0.62%.Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lamivudine in tablet dosage form. The method could be considered for the determination of Lamivudine in quality control laboratories.

scholarly journals Preparation of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and development of quality control methods

2021 ◽  
Vol 10 (2) ◽  
pp. 62-67
Author(s):  
A. M. Domanina ◽  
M. V. Chernikov ◽  
I. P. Remezova ◽  
E. F. Stepanova ◽  
A. M. Shevchenko ◽  
...  
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Chemical Properties ◽  
Antimicrobial Effect ◽  
Film Coating ◽  
Technological Properties ◽  
Physico Chemical ◽  
The Stability ◽  
Object Of Study

Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α] benzimidazole (DFDB).Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.

Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

2021 ◽  
pp. 5813-5818
Author(s):  
Rama Kumar Kandula ◽  
Raja Sundararajan
Keyword(s):  
Quality Control ◽  
Simultaneous Determination ◽  
Mobile Phase ◽  
Dosage Form ◽  
Regression Equations ◽  
Control Test ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Quality Control Test

Aim: To Perform Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin Tablet dosage form developed in a simple, Accurate, precise manner. Method: Agilent C18 150 x 4.6mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min used for the development of chromatogram. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260nm. Results and Conclusion: Retention time of Saxagliptin, Dapagliflozin and Metformin were found to be 2.253 min, 2.720 min, 3.276 min respectively. % RSD of the Saxagliptin, Dapagliflozin and Metformin were and found to be 0.8, 0.2 and 0.6. % Recovery was obtained as 99.60%, 100.07% and 99.95% for Saxagliptin, Dapagliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Saxagliptin, Dapagliflozin and Metformin were 0.06, 0.12, 9.61 and 0.17, 0.36, 29.31 respectively. Regression equation of Saxagliptin is y = 40882x + 889.2, Dapagliflozin is y = 47904x + 3897 and Metformin is y = 4530.x + 35785. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

A New Ecological HPLC Method for Determination of Vancomycin Dosage form

2020 ◽  
Vol 7 (2) ◽  
pp. 82-90
Author(s):  
Patricia Aleixa do Nascimento ◽  
Ana Carolina Kogawa ◽  
Hérida R.N. Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Acetic Acid ◽  
Dosage Form ◽  
Uv Light ◽  
Hplc Method ◽  
Green Analytical Chemistry ◽  
Vancomycin Dosage ◽  
Routine Quality Control

Aims: To develop and validate a new ecological HPLC method for the determination of vancomycin dosage form. Background: Vancomycin is an important antimicrobial. According to the literature, there are many methods that use HPLC, but none of these methods follow the green analytical chemistry principles. Objective: Therefore, a green analytical method to quantify vancomycin in lyophilized powder for injectable solution by HPLC was developed. Materials and Methods: It uses less quantity of toxic solvents, minimizing the costs and optimizing the time of analysis. Water + 0.1% acetic acid and ethanol (85:15, v/v), 0.5 mL min-1, and C18 column (15 cm) at 280 nm were used. Results and Discussion: The method was linear in the range of 40 to 140 μg mL-1, with a correlation coefficient of 0.9998. It was selective when subjected to acid 0.1M, basic 0.01M, oxidative 0.3%, UV light and neutral degradation in a bath of 60 ºC for 8 hours. The precision of the method was proved at intraday (RSD 1.08%), interday (RSD 0.47%) and intermediate levels (RSD 2.35%). It was accurate with a mean recovery of 100.19% and robust when changes were performed in seven parameters of the method and analyzed by the Youden and Steiner test. Conclusion: The method can be applied to routine quality control of vancomycin lyophilized powder for injectable solution as an ecological and sustainable alternative that contemplates the green analytical chemistry and the current pharmaceutical analyses.

scholarly journals UV Spectrophotometric Method for Determination of Cinitapride in Pure and its Solid Dosage Form

2009 ◽  
Vol 6 (s1) ◽  
pp. S21-S24 ◽  
Author(s):  
B. Thangabalan ◽  
A. Elphine Prabahar ◽  
R. Kalaichelvi ◽  
P. Vijayaraj Kumar
Keyword(s):  
Quality Control ◽  
Spectrophotometric Determination ◽  
Spectrophotometric Method ◽  
Analytical Method ◽  
Dosage Form ◽  
Spectrophotometric Assay ◽  
Solid Dosage ◽  
Quality Control Testing ◽  
Routine Quality Control

A new, rapid, precise, accurate and sensitive analytical method was developed for the UV spectrophotometric assay of cinitapride (CTP). The drug obeyed the Beer's law and showed good correlation. It showed absorption maxima at 260 nm in methanol. The linearity was observed between 5-40 µg mL-1. The results of analysis were validated by recovery studies. The recovery was more than 99%. The proposed method is the only method available for spectrophotometric determination of the drug. It is simple, precise, sensitive and reproducible and can be used for the routine quality control testing of the marketed formulations.

High-performance thin-layer chromatographic determination of rosiglitazone in its dosage form

2002 ◽  
Vol 15 (3) ◽  
pp. 192-195 ◽  
Author(s):  
Ramesh Sane ◽  
Mary Francis ◽  
Atul Moghe ◽  
Sachin Khedkar ◽  
Ajit Anerao
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Determination

UV spectroscopic method for determination of phenytoin in bulk and injection forms

2019 ◽  
Author(s):  
Chem Int
Keyword(s):  
Quality Control ◽  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Routine Quality Control

Recent study was conducted to develop a simple UV spectrophotometric method to determine Phenytoin in bulk and injection form according to official requirement and validate as per ICH guidelines. λmax of Phenytoin was found 202 nm. Linearity existed perceived in the concentration assortment 2-8 μg/ml (r2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The existent method was establish to be simple, linear, precise, accurate as well as sensitive and can be applied for routine quality control enquiry for the analysis of Phenytoin in bulk and injection form.

Sign in / Sign up

Export Citation Format

Share Document