scholarly journals DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTIFICATION OF DACLATASVIR IN PURE AND SOLID DOSAGE FORM

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
Nida Saeed ◽  
Muhammad Shaharyar Afridi ◽  
Abida Latif ◽  
Hafiz Hanzalah Fahham ◽  
Itzaz Aslam ◽  
...  
2010 ◽  
Vol 7 (3) ◽  
pp. 947-952 ◽  
Author(s):  
Rajesh Sharma ◽  
Ganesh Prasad Mishra ◽  
Subhash Chandra Chaturvedi

A simple, sensitive, precise, accurate, rapid and reproducible reverse phase high performance liquid chromatographic procedure is developed for simultaneous determination of rabeprazole sodium and itopride hydrochloride in solid dosage form. The mobile phase used was a combination of acetonitrile: buffer (35:65 v/v) and the pH was adjusted to 7.0 ± 0.1 by addition of triethylamine. The detection of the capsule dosage form was carried out at 266 nm and a flow rate employed was 1 mL/min. Linearity was obtained in the concentration range of 2 to 16 μg/mL of rabeprazole sodium and 5 to 55 μg/mL of itopride hydrochloride with a correlation coefficient of 0.9992 and 0.9996 respectively. The results of the analysis were validated statistically and recovery studies confirmed the accuracy of the proposed method.


Author(s):  
Sara Zahid ◽  
Fatima Zahid ◽  
Asma Ahmed ◽  
Waqas Safir

Pioglitazone is a drug that reduces the amount of glucose (sugar) in the blood. It is included in the class of anti-diabetic drugs called “thiazolidinedione” that are used in the treatment of type II diabetes. It attaches to the peroxisomes proliferated- activated receptor gamma (PPARϒ) on tissues throughout the body and causes the cells to become more sensitive to insulin. As a result, more glucose is removed from the blood.The aim of the study is more precisely to find out the better analytical method for the quantitative measurement of the content of pioglitazone in commercially available drugs using two analytical methods i-e Spectrophotometric method and HPLC method.The analytical method for the pioglitazone hydrochloride was developed by HPLC, and then validated the method according to compendial requirements. Pioglitazone in various Dowglit and Gliden tablets was determined by this developed methodPrecision, Accuracy and stability of Pioglitazone was checked which came out to be100.40% and 100.19% respectively. The analysis of pioglitazone hydrochloride in solid dosage form using the HPLC method shows the results are more sensitive, accurate, validated and economical and can be easily applied to raw materials and finished goods compared to the Spectrophotometer method.


2021 ◽  
Vol 8 (3) ◽  
pp. 129-133
Author(s):  
Manisha Masih

A rapid, sensitive, specific, accurate and precise high pressure liquid chromatographic method (HPLC) method involving UV detection has been developed for the determination and quantification of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form. The determination was carried out on a Phenomenex C18 column (Dimention : 250 x 4.6 mm, 5 μm). The sample was analysed using filtered and degassed mixture of methanol : 0.1N HCl (1:1) as mobile phase at a flow rate of 1ml/min and effluent was monitored at 218nm. The retention time for Amlodipine besylate was 7.6 min and for Enalapril maleate 3.2 min. Amlodipine besylate and Enalapril maleate showed a linear response in the concentration range of 10-50μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Enalapril maleate was 0.9992 and 0.9994, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be used for routine analysis of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form


Author(s):  
Asha Thomas ◽  
Suraj Bhosale ◽  
Rabindra Nanda

Objective: The verify now P2Y12 assay suggested that addition of cilostazol to clopidogrel proves to be efficious in the treatment of patients with cardiovascular disease (CVD). Based on these findings, an attempt has been made to formulate solid dosage form containing the two drugs at the recommended concentrations and develop and validate reverse phase high-performance liquid chromatography (HPLC) method for their simultaneous estimation.Methods: A combined tablet dosage form containing cilostazol (100 mg) and clopidogrel (75 mg) was formulated by direct compression method. A reverse phase HPLC method using C8 column, employing 0.025M phosphate buffer: methanol: acetonitrile (20:40:40% v/v) as mobile phase at a flow rate of 1 ml/min with ultraviolet (UV) detection at 237 nm was developed and validated as per International Council on Harmonisation (ICH) guidelines.Results: The prepared powder blend showed excellent flow properties and formulated tablet passed the standard tests for tablets. The tablets were suitably analyzed by the reverse phase HPLC method with a retention time (RT) of 3.82 and 7.72 min for cilostazol and clopidogrel respectively. The method exhibited linearity (10-100mg/ml for cilostazol and 7.5-75mg/ml for clopidogrel) with r2= 0.999 for both drugs respectively. The recoveries of cilostazol and clopidogrel were 98.97% and 98.94% respectively. The relative standard deviation (RSD) was<2% indicating good method precision. The stability indicating properties evaluated by forced degradation studies showed good separation of the drugs from their degradation products.Conclusion: A simple, precise, robust, stability-indicating HPLC method was developed for simultaneous assay of cilostazol and clopidogrel in prepared tablet formulation and validated as per ICH guidelines. This method can be employed for the analysis and stability studies of solid dosage forms containing the two drugs.


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