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.

scholarly journals RP-HPLC method development for simultaneous estimation of empagliflozin, pioglitazone, and metformin in bulk and tablet dosage forms

2021 ◽  
Vol 78 (3) ◽  
pp. 305-315
Author(s):  
RAZAN AHMAD ◽  
Mohammad Hailat ◽  
MALAK JABER ◽  
BAYAN ALKHAWAJA ◽  
AMMAR RASRAS ◽  
...  
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Tablet Dosage

scholarly journals Method development and method validation of guaifenesin and dextromethorphan by RP-HPLC

2018 ◽  
Vol 1 (1) ◽  
pp. 18-24
Author(s):  
P. Salomi ◽  
D. Mahendra Nayak ◽  
T. Vimalakannan ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Isocratic Mode ◽  
Good Percentage

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Guaifenesin and Dextromethorphan was successfully achieve THERMO, C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1M KH2PO4: Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 3.259 and 4.164 minutes for Guaifenesin and Dextromethorphan respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Guaifenesin and 50µg/ml to150 µg/ml for Dextromethorphan. The values of the correlation coefficient were found to 0.999 for Guaifenesin and 1for Dextromethorphan. respectively. The LOD and LOQ for Guaifenesin were found to be 0.597 and 1.991 respectively. The LOD and LOQ for Dextromethorphan were found to be 0.1072 and 0.3572 respectively. This method was found to be good percentage recovery for were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

Sign in / Sign up

Export Citation Format

Share Document