Quantitative Estimation and Validation of Dapagliflozin and Metformin Hydrochloride in Pharmaceutical Dosage form by RP-HPLC

2019 ◽  
Vol 12 (3) ◽  
pp. 136
Author(s):  
Nachiket S. Dighe ◽  
Priyanka R. Varade ◽  
Ganesh S. Shinde ◽  
Priya S. Rao
Keyword(s):  
Dosage Form ◽  
Quantitative Estimation ◽  
Metformin Hydrochloride ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF VITAMIN-D3 IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (06) ◽  
pp. 40-45
Author(s):  
T Mohan ◽  
◽  
S Prabhakara ◽  
K Anbazhagan ◽  
Krishnan Pavithra ◽  
...  
Keyword(s):  
Vitamin D3 ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Control Analysis ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Bulk Drug

An accurate, simple, rapid, sensitive and cost effective method for the determination of Vitamin-D3 in pharmaceutical dosage form was developed and validated by RP-HPLC method. Chromatographic separation was achieved on phenomenex C18 column (150 mm X 4.6 mm, 5μm) using methanol: acetonitrile: water (90:5:5 V/V/V) as mobile phase, at a flow rate of 1.5 mL/min. The retention time of Vitamin-D3 was found to be 8.3 minutes; the detection was monitored at 265 nm by using UV detector. The developed method was validated according to International Conference on Harmonization (ICH) guidelines. The linearity of Vitamin-D3 was in the range of 2.50 ppm to 6.00 ppm. This method showed an excellent linear response with the correlation coefficient (R2) value of 0.999 for the Vitamin-D3. The recovery of the drug ranged from 99.59% to 103.83% with an average of 101.34%. The percentage RSD was found to be less than two, indicating high degree of accuracy and precision of the proposed RPHPLC method. Due to simplicity, cost effectiveness, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis of Vitamin-D3 in bulk drug and pharmaceutical dosage forms.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 10 (10) ◽  
pp. 50
Author(s):  
Pooja Pisal ◽  
Ganesh Nigade ◽  
Amol Kale ◽  
Smita Pawar
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard

Objective: To develop a novel, accurate, precise and linear reverse phase high-performance liquid chromatography (RP-HPLC) and Stability Indicating Assay Method (SIAMs) for simultaneous, qualitative and quantitative estimation of aspirin, rosuvastatin and clopidogrel in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines.Method: In the present work, good chromatographic separation was achieved by isocratic method using a BISCOF HPLC C18 column (250 mm ×4.6, 5 µm) and a mobile phase consisting of water at pH 2.51 with 0.1 % (v/v) orthophosphoric acid (OPA): acetonitrile in the ratio 50:50, at a flow rate of 1 ml/min. The effluents obtained were monitored at 237 nm with the UV-visible detector.Results: The retention time of aspirin, rosuvastatin, and clopidogrel was found to be 4.3 min, 7.6 min and 16.6 min respectively. For linearity seven-point calibration curves were obtained in a concentration range from 1-7 µg/ml for aspirin, rosuvastatin and clopidogrel with correlation coefficient 0.999, 0.9989, 0.9988 respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise. In the present study stability indicating an RP-HPLC method for the combination was tested by degrading the drugs together under various stress condition like acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH.Conclusion: The developed RP-HPLC method is simple, economic, specific, accurate and precise for the simultaneous estimation of aspirin, rosuvastatin, and clopidogrel in the combined capsule dosage form. The developed stability indicating analytical method can be used to check the stability of the compounds and was found suitable to determine % degradation of drugs in pharmaceutical dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR PHENYTOIN SODIUM AND PHENOBARBITONE IN BULK AND PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (10) ◽  
pp. 224
Author(s):  
Radhika Shah ◽  
Ragin Shah
Keyword(s):  
Dosage Form ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Phenytoin Sodium ◽  
Pharmaceutical Industries ◽  
Development And Validation ◽  
Tablet Dosage

Objective: To develop an accurate, simple, rapid, precise, and linear RP-HPLC method for the simultaneous estimation of phenytoin sodium and phenobarbitone in tablet dosage form and validated as per ICH guidelines.Methods: The method used was a reverse phase HPLC (RP-HPLC) method using Hypersil BDS C18, (250×4.6 mm, 5 μm) column, mobile phase comprising of methanol: phosphate buffer (pH 5.0) (50:50), flow rate of 1.0 ml/min and a detection wavelength of 215 nm using a UV detector.Results: The retention time for phenytoin sodium and phenobarbitone was found to be 3.97 min and 6.90 min, respectively. The linearity of developed method was achieved in the range of 10-30 μg/ml for phenytoin sodium and 3-9 μg/ml for phenobarbitone. The detection (LOD) and quantitation (LOQ) limits were 1.44 and 4.36 µg/ml for phenytoin sodium and 0.40 and 1.35 µg/ml for phenobarbitone respectively.Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of phenytoin sodium and phenobarbitone in bulk and pharmaceutical formulation. The method was validated as per ICH guidelines. Hence, the method holds good for the routine analysis of phenytoin sodium and phenobarbitone in various pharmaceutical industries as well as in academics.

scholarly journals Analytical Method Development and Validation for the Simultaneous Estimation of Aspirin, Clopidogrel and Rosuvastatin in Pharmaceutical Dosage Form

2019 ◽  
Vol 9 (4-s) ◽  
pp. 432-438
Author(s):  
Pradip Kumar Tiwari ◽  
Amit Jain ◽  
BK Dubey ◽  
GK Pandey ◽  
Suresh Dhakad
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Relative Standard

A new, simple, novel, accurate, precise, reliable, rapid and linear reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and fully validated for simultaneous qualitative and quantitative estimation of   Rosuvastatin (ROS), Clopidogrel (CLOP) and Aspirin (ASP) in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines. In the present work, good chromatographic separation was achieved by isocratic method using a Hypersil BDS C18 column (250 mm ×4.6, 5 μm) and a mobile phase consisting of KH2Po4 buffer pH-6.0: acetonitrile in the ratio 60:40, at a flow rate of 1 ml/min. The effluents obtained were monitored at 242nm with the UV-visible detector. The calibration curves obtained were linear (r2=0.999) over the concentration range of 7.5-22.5μg/ml and 1-3μg/ml for CLOP, ASP and ROS respectively. A run time of 7.0 minutes for each sample made it possible to analyze more than 200 samples per day. The retention time of ASP, CLOP and ROS was found to be 3.103 min, 4,277 min and 5.707 min respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise  therefore the method can be used for routine monitoring of CLOP, ASP and ROS in industry in the assay of bulk drug and dosage form. Keywords: RP-HPLC, Rosuvastatin, Clopidogrel, Aspirin, Method validation, ICH guidelines.

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