scholarly journals Development and Validation of Dimeric Macrocyclic Tannin Assay Method in Dosage Forms

2020 ◽  
Vol 9 (4) ◽  
pp. 93-98
Author(s):  
E. V. Ignаteva ◽  
I. V. Yartseva ◽  
Z. S. Shprakh ◽  
I. R. Prosalkova ◽  
S. A. Sasov ◽  
...  
Keyword(s):  
Active Substance ◽  
Quantitative Assessment ◽  
Dosage Forms ◽  
Assay Method ◽  
Uv Spectrophotometry ◽  
Drug Form ◽  
Development And Validation ◽  
Antiangiogenic Drug ◽  
Drug Quality Control

Introduction. Quantitative assessment of the active substance is necessary and perhaps the most significant part of the drug quality control. Validation of the analytical methods of quantitative assessment ensures their compliance with high requirements. The present study describes the development and validation of a spectrophotometry method for the quantitative evaluation of the active substance in the drug form of the national antitumor and antiangiogenic drug «Dimeric macrocyclic tannin (DMT) lyophilizate for solution for injection, 100 mg».Aim. The development and validation of the assay method for the standardization of «DMT lyophilizate for solution for injection, 100 mg».Materials and metods. The study used «DMT lyophilizate for solution for injection, 100 mg» and the active substance DMT. Method – spectrophotometry.Results and discussion. The methodof the quantitative assessment of the active substance in the DMT lyophilized drug by direct UV spectrophotometry was developed and the validation characteristics of the method were defined as a result of the study.Conclusion. The validation results showed that the assay method of DMT in the drug form has the appropriate accuracy, precision and linearity. The obtained results correspond to the approved criteria that allow the use of the developed methodology for evaluating the quality of the drug.

scholarly journals EFFECT OF SOLID DISPERSIONS ON THE SOLUBILITY OF METRONIDAZOLE

2021 ◽  
Vol 9 (3) ◽  
pp. 195-204
Author(s):  
I. I. Krasnyuk (Jr.) ◽  
S. R. Naryshkin ◽  
I. I. Krasnyuk ◽  
A. V. Belyatskaya ◽  
O. I. Stepanova ◽  
...  
Keyword(s):  
Optical Properties ◽  
Solid Dispersion ◽  
Active Substance ◽  
Solid Phase ◽  
Solid Dispersions ◽  
Dosage Forms ◽  
Polyethylene Glycols ◽  
Uv Spectrophotometry ◽  
Colloidal Solutions ◽  
Constant Weight

The aim of the work is to study the effect of solid dispersions using polyethylene glycols of various molecular weights on the solubility of metronidazole in water. Metronidazole is an antimicrobial and antiprotozoal drug. Its low solubility in water limits the use of metronidazole, causing technological difficulties and reducing its bioavailability. The solubility and release of the active substance from dosage forms can be increased using the solid dispersion methods. Solid dispersions are bi- or multicomponent systems consisting of an active substance and a carrier (a highly dispersed solid phase of the active substance or molecular-dispersed solid solutions) with a partial formation of complexes of variable compositions with the carrier material.Materials and methods. The substance of metronidazole used in the experiment, was manufactured by Hubei Hongyuan Pharmaceutical Technology Co., Ltd. (China). To obtain solid dispersions, polyethylene glycols of various molar masses – 1500, 2000 and 3000 g/mol – were used. The solid dispersions were prepared by “the solvent removal method”: metronidazole and the polymer were dissolved in a minimum volume of 96% ethyl alcohol (puriss. p.a./analytical grade) at 65±2°C, and then the solvent was evaporated under vacuum to the constant weight. A vacuum pump and a water bath were used at the temperature of 40±2°C. The dissolution of the samples was studied using a magnetic stirrer with heating, and a thermostatting device. The concentration of metronidazole was determined on a spectrophotometer using quartz cuvettes at the wavelength of 318±2 nm. To filter the solutions, syringe nozzles were used, the pores were 0.45 μm, the filter was nylon. Microcrystalloscopy was performed using a microscope with a digital camera. The optical properties of the solutions were investigated using a quartz cuvette and a mirror camera (the image exposure – 20 sec).Results. Obtaining solid dispersions increases the completeness and rate of the metronidazole dissolution. The solubility of metronidazole from solid dispersions increases by 14–17% in comparison with the original substance. The complex of physical-chemical methods of the analysis, including UV spectrophotometry, microcrystalloscopy and the study of the optical properties of the obtained solutions, makes it possible to suggest the following. The increase in the solubility of metronidazole from solid dispersions is explained by the loss of crystallinity and the formation of a solid solution of the active substance and the solubilizing effect of the polymer with the formation of colloidal solutions of metronidazole at subsequent dissolution of the solid dispersion in water.Conclusion. The preparation of solid dispersions with polyethylene glycols improves the dissolution of metronidazole in water. The results obtained are planned to be used in the development of rapidly dissolving solid dosage forms of metronidazole with an accelerated release and an increased bioavailability.

scholarly journals The metrological parameters of diosmin quantitation in pharmaceutical dosage forms

2020 ◽  
Vol 20 (5-6) ◽  
pp. 151-156
Author(s):  
Alexander V. Voronin ◽  
Maksim N. Kachalkin ◽  
Alexander V. Karpov
Keyword(s):  
Quality Control ◽  
Sample Preparation ◽  
Sodium Hydroxide Solution ◽  
Dosage Forms ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Forms ◽  
Drug Quality ◽  
Specific Absorbance ◽  
Metrological Parameters ◽  
Drug Quality Control

Introduction. Pharmaceutical dosage forms with diosmin are allowed for medical use in Russian Federation. Simple and informative methods of diosmin quantitation for drug quality control are needed. Aim: determination of metrological parameters of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry. Matherials and methods. The study subjects Venarus, Detralex (tablets, suspension), Phlebopha. Diosmin were quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 and 370 nm by the parameters of calibration were determined. Statistical data processing was carried out by the methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA). Results. The range of diosmin quantitation by UV-spectrophotometry was revealed for the wavelength of 268 nm 0,0001-0,001%, 370 nm 0,0002-0,002%. The reference-specific absorbance values for diosmin at the wavelength of 268 and 370 nm in a sodium hydroxide solution 0,02M were 463,0 24,6 and 259,0 9,9 respectively. The mean errors of diosmin concentrations in pharmaceutical dosage forms were revealed for the wavelength of 268 nm 8-12% and for 370 nm 6-8%. Prognostic calculation of the sample preparation error (extraction) for diosmin was performed using the example of Detralex tablets. The sample preparation error was 8%. Conclusion. The values components of error for reference-specific absorbance value and sample preparation error for diosmin quantitation were determined (as exemplified by the study of Detralex tablets). Calculation algorithms can be used for error estimation of sample preparation for other multicomponent samples in drug quality control.

scholarly journals UV Spectroscopy Assay Method Development and Validation of Dimethyl Fumarate and Cyclosporine Drugs in Nano Dosage Forms

2020 ◽  
Vol 11 (01) ◽  
pp. 196-204
Author(s):  
Deepa Patel ◽  
Sneha Patel ◽  
Drashti Pathak
Keyword(s):  
Method Development ◽  
Uv Spectroscopy ◽  
Dimethyl Fumarate ◽  
Dosage Forms ◽  
Spectroscopic Technique ◽  
Assay Method ◽  
System Suitability ◽  
Line Equation ◽  
Method Development And Validation ◽  
Development And Validation

An easy, precise and accurate spectroscopic technique for the estimation of cyclosporine and dimethylfumarate in pure form and nano dosage form has been developed. The proposed method involves dissolving dimethylfumarate in distilled water and cyclosporine in ethanol and subjecting resulting solution to UV spectroscopic assessment. Absorption maximum was found 210 and 214 nm respectively. Beer’s law was obeyed in the concentration range of 1 to 5and 1 to 8 μg/mL for dimethylfumarate and cyclosporine. Calibration curve showd linearity between absorbance and concentration as per line equation with R2 value near 1. Validation was performed as ICH guildelines for linearity, accuracy, precision, Robustness, System suitability.

scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Ceftaroline Fosamil in Bulk and Its Parenteral Dosage Forms

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
A. Suneetha ◽  
K. China Venkanna
Keyword(s):  
Degradation Products ◽  
Active Pharmaceutical Ingredient ◽  
Dosage Forms ◽  
Hplc Method ◽  
Assay Method ◽  
Pharmaceutical Dosage Forms ◽  
Ceftaroline Fosamil ◽  
Rp Hplc ◽  
Development And Validation

The present method describes the development of a validated RP-HPLC method for determination of ceftaroline fosamil in presence of its degradation products or other pharmaceutical excipients. The drug substance was subjected to stress conditions of acid, alkali, and oxidative and thermal degradation studies. Separation was carried out on a C-18 X-terra column (Waters Corporation, 250 mm × 4.6 mm I.D.; particle size 5 μm) using 40 : 30 : 30 [buffer : acetonitrile : methanol] as mobile phase at a flow rate of 1.0 ml/min. UV detection was performed at 242 nm. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision, and robustness. The assay method was found to be linear in the range of 40 to 120 μg/mL with a correlation coefficient of 0.9999. The percentage recovery of active pharmaceutical ingredient from parenteral dosage form ranged from 99.5 to 100.2%. The method precision for determination of ceftaroline was below 0.85%. The results showed that the developed RP-HPLC method is suitable for determination of ceftaroline fosamil in bulk as well as stability samples of pharmaceutical dosage forms containing various excipients.

A Review on Analytical Methods of Irbesartan and its Combinations in Pharmaceutical Dosage Forms

2020 ◽  
Vol 16 (8) ◽  
pp. 1020-1029 ◽  
Author(s):  
Calamur Nagarajan Nalini ◽  
Nivedhitha Mathivanan
Keyword(s):  
Method Development ◽  
Analytical Techniques ◽  
Dosage Forms ◽  
Angiotensin Ii Receptor Blocker ◽  
Uv Spectrophotometry ◽  
Angiotensin Ii Receptor ◽  
Research Activity ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
Development And Validation

Pharmaceutical analysis plays an indispensable role in various stages of drug pipeline including drug development, fabrication of formulation, stability studies and quality control. It is also used for characterizing the composition of different dosage forms in quantitative and qualitative ways. Comprehensive literature survey forms the foundation stone for the focused analysis of research activity. Irbesartan is a hypertension antagonist chiefly employed in the treatment of high blood pressure which is an Angiotensin II Receptor blocker. The multiple mixtures of various antihypertensive medicaments raise challenges in the method development and validation. A genuine venture is undertaken to compile the literatures related to the antihypertensive drug Irbesartan published in various peer reviewed journals. HPLC and UV spectrophotometry are the most preferred analytical techniques when compared to other methods. This present review provides an in-depth assortment of various analytical techniques published for Irbesartan and its combinations, which will help the researchers in their future endeavors.

scholarly journals Development and validation of new analytical method for the estimation of fluoxetine in bulk and dosage form by UV spectrophotometry

2019 ◽  
Vol 1 (2) ◽  
pp. 36-39
Author(s):  
Uday sankar raju K ◽  
Vimalakkannan T ◽  
K. Ravindra Reddy ◽  
P. Naveena ◽  
R. Riharika raj ◽  
...  
Keyword(s):  
Standard Deviation ◽  
Quantitative Determination ◽  
Dosage Form ◽  
Dosage Forms ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Forms ◽  
Precise Method ◽  
Absorbance Measurement ◽  
Development And Validation

A simple, rapid and precise method is developed for the quantitative determination of Fluoxetine in combined pharmaceutical-dosage forms. The method was based on UV Spectrophotometric determination of Fluoxetine drug using Beer-Lamberts Law. It involves absorbance measurement at 224 nm (λmax of Fluoxetine) in water. For UV Spectrophotometric method, linearity was obtained in concentration range of 5-30 mcg/ml with regression 0.999 for Fluoxetine respectively. Recovery was in the range of 98 -102%; the value of standard deviation and %R.S.D was found to be < 2 shows high precision of the method..

scholarly journals Development and validation of new analytical method for the simultaneous estimation of omeprazole and domperidone in pharmaceutical dosage form by UV spectrophotometry

2019 ◽  
Vol 1 (2) ◽  
pp. 44-46
Author(s):  
V. Pavan Kumar ◽  
C. Bhanu Chandra ◽  
N. Devendra ◽  
M. Kishor Kumar ◽  
S. Reddy Basha ◽  
...  
Keyword(s):  
Dosage Form ◽  
Simultaneous Equation ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Development And Validation

A simple, rapid and precise method was developed for the quantitative simultaneous determination of Omeprazole and Domperidone in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 291 nm (λmax of Omeprazole) and 289 nm (λmax of Domperidone) in Methanol: Acetonitrile (30:70 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 µg/ml for Domperidone and 1-50 µg/ml for Omeprazole respectively, with regression 0.999 and 0.999 for Domperidone and Omeprazole respectively. Recovery was in the range of 99 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.

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