scholarly journals QUALITY CONTROL MEASUREMENT AND IN VITRO BIOEQUIVALENCE OF VALSARTAN AND ATENOLOL TABLETS MARKETED IN UKRAINE

2021 ◽  
Vol 6 (2) ◽  
pp. 52-58
Author(s):  
K. Y. Peleshok
Keyword(s):  
Quality Control ◽  
Method Development ◽  
Disease Risk ◽  
Pharmaceutical Preparation ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Dissolution Profile ◽  
Control Measurement ◽  
Dissolution Tests

Background. The urgent issue of hypertension is determined by its high population incidence, significant burden of the disease, risk of disability and impact on life expectancy. Rational combinations of drugs of different pharmacological groups in case of ineffectiveness of monotherapy to achieve the clinical effect of pharmacotherapy are clearly recommended in the world and national recommendations for diagnosis and treatment of hypertension. Therefore, innovative pharmaceutical development of a combination of antihypertensive drugs and creation of domestic drugs with antihypertensive action is an urgent task of contemporary pharmacy. Objective. The aim of this study was to perform the quality control measurements and evaluation of dissolution tests for different brands of valsartan and atenolol tablets available in Ukraine. Methods. The concentrations of valsartan and atenolol in samples (drug content and dissolution study) were determined by the proposed HPLC method. Results. The results of the tests conducted for evaluation of the tablets were found to be in acceptable limits for all the selected brands. The correlation coefficient (R2) was 0.9991 and the regression equation was y=61.39x+0.3117. It has been established that the equivalence of dissolution profiles for all recommended dissolution media is observed (рН 1.2, 4.5, and 6.8) for the studied drugs. In all three dissolution media, the release rates of valsartan and atenolol of all dosage forms are more than 85% in 15 min. The dissolution profile of all the selected brands was within the standard limits and was acceptable. Conclusions. Analytical method development is an integral part of the quality control measurements and evaluation of dissolution tests. Our previously developed HPLC method is essential for quality control of a large number of samples in short time intervals. Therefore, the method developed by our group is suitable for a routine quality control analysis of any pharmaceutical preparation containing two tested drugs with the suggested chromatographic method advantages for checking quality during dissolution studies of their dosage forms.

scholarly journals Development, Estimation and Validation of Lisinopril in Bulk and its Pharmaceutical Formulation by HPLC Method

2012 ◽  
Vol 9 (1) ◽  
pp. 340-344 ◽  
Author(s):  
V. Bhaskara Raju ◽  
A. Lakshmana Rao
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Quality Control Analysis ◽  
Tablet Dosage ◽  
Routine Quality Control

An accurate and preciseHPLCmethod was developed for the determination of lisinopril. Separation of the drug was achieved on a reverse phase C8column using a mobile phase consisting of phosphate buffer and methanol in the ratio of 35:65v/v. The flow rate was 0.8 mL/min and the detection wavelength was 215 nm. The linearity was observed in the range of 20-60 μ g/mL with a correlation coefficient of 0.9992. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of lisinopril in tablet dosage forms.

A New, Rapid and Simple RP-HPLC Method for Stability Quantification of a Protease Inhibitor in Tablets

2021 ◽  
Author(s):  
Rochele Cassanta Rossi ◽  
Josué Guilherme Lisbôa Moura ◽  
Vanessa Mossmann ◽  
Patrícia Weimer ◽  
Pedro Eduardo Fröehlich
Keyword(s):  
Quality Control ◽  
Protease Inhibitor ◽  
Degradation Products ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Forced Degradation ◽  
Control Analysis ◽  
Quality Control Laboratory ◽  
The Stability

Abstract Fosamprenavir calcium is a protease inhibitor widely used in the treatment and prevention of human immunodeficiency virus and acquired immunodeficiency syndrome. This protease inhibitor serves as a prodrug of amprenavir, offering better oral bioavailability. Although this drug was approved by the FDA in 2003, there are few methods established for quantifying the stability for quality control analysis of fosamprenavir-coated tablets. The purpose of the study was to develop and validate a method for determining the stability of fosamprenavir-coated tablets (Telzir®) that may be applied by any quality control laboratory. Chromatographic separation was performed using a Vertical RP-18 column programmed to run a gradient elution with sodium acetate buffer and acetonitrile. Flow rate was 1.2 mL min−1 for a total run time of 15 min. Ultraviolet detection was set at 264 nm and the use of a photodiode array detector in scan mode allowed selectivity confirmation by peak purity evaluation. The analyte peak was found to be adequately separated from degradation products generated during forced degradation studies. Thus, the proposed method was found to accurately indicate stability and was sufficient for routine quantitative analysis of fosamprenavir in coated tablets without interference from major degradation products and excipients.

DEVELOPMENT AND VALIDATION OF RP-HPLC-PDA METHOD FOR THE ESTIMATION OF SARPOGRELATE HYDROCHLORIDE IN BULK AND DOSAGE FORMS

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (04) ◽  
pp. 77-80
Author(s):  
M Vijaya Lakshmi ◽  
◽  
K Hima Bindu ◽  
M. Pravallika ◽  
B. N. Nalluri
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Anti Platelet Drug ◽  
Sarpogrelate Hydrochloride ◽  
The Mean ◽  
Development And Validation

A simple and precise RP-HPLC method has been developed and validated for the estimation of sarpogrelate hydrochloride, an anti-platelet drug in bulk and pharmaceutical dosage forms. Sarpogrelate is an antagonist at 5HT2A and 5HT2B receptors which blocks serotonin induced platelet aggregation and has application in the treatment of diseases including diabetes mellitus, Raynaud’s disease, angina pectoris and atherosclerosis. Chromatography was carried out on a Phenomenex C18 (250 x 4.6mm, 5μm) column with a mobile phase of 10mM ammonium acetate and acetonitrile (45:55% v/v). The flow rate was 1.2mL/min. The detection wavelength was carried out at 220nm. The retention time is 3.356 minutes for sarpogrelate hydrochloride. The linearity was found in the range of 10-50 μg/ml (R = 0.999) and % RSD is less than 2%. The mean recoveries obtained for sarpogrelate hydrochloride were in the range of 98.73-100.67%. The method is validated as per ICH guidelines and can be applied for the estimation of percentage purity in Sarpogrelate hydrochloride for quality control analysis in bulk and its dosage forms.

Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms

2021 ◽  
pp. 111-118
Author(s):  
Kapil Rana ◽  
Pushpendra Sharma
Keyword(s):  
Method Development ◽  
Analytical Techniques ◽  
Dosage Forms ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Gradient System ◽  
Control Analysis ◽  
Uv Detector ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The day by day new combinations drugs are being introduced in market. Then the multiple therapeutic agents which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combinations. An accurate, precise and reproducible RP-HPLC method was developed for the simultaneous quantitative determination of Metformin Hydrochloride (MET) and Alogliptin (ALO) in tablet dosage forms. Methods: Younglin (S. K.) gradient system UV detector and C18 column with 250 mm x 4.6 mm i. d. and 5μm particle size Acetonitrile: OPA water (80: 20v/v) pH 2.5 was used as the mobile phase for the method. The detection wavelength was 283 nm and flow rate was 0.9ml/min. Results: In the developed method, the retention time of MET and ALO were found to be 6.366 min and 8.616 min. The developed method was validated according to the ICH guidelines. Conclusion: In this methods linearity, precision, range, robustness were observed. The method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of MET and ALO in bulk drug as well as in formulations.

RP-HPLC Method Development and Validation of Bicalutamide and Atenolol in its Pure Dosage Forms

2020 ◽  
Vol 10 (1) ◽  
pp. 15
Author(s):  
Prem Kumar Bichala ◽  
R. Suthakaran ◽  
Ch. Shankar ◽  
Syed Ghouse ◽  
Jannet Beula ◽  
...  
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation
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