Method Development and Validation of Propofol by Reverse Phase HPLC and its Estimation in Commercial Formulation

2021 ◽  
pp. 3139-3142
Author(s):  
Kuntal Mukherjee ◽  
S. T. Narenderan ◽  
B. Babu ◽  
Survi Mishra ◽  
S. N. Meyyanathan
Keyword(s):  
High Performance ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reverse Phase Hplc ◽  
Liquid Chromatographic Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, sensitive and rapid high performance liquid chromatographic method has been developed for the determination of Propofol. The main focus of the method was to determine Propofol in solution form as well as in marketed formulation. Chromatographic separation was achieved on Inertsil ODS-3V column (250mm x 4.6mm; 5µm) with a mobile phase consisting of methanol: water (85:15), with a flow rate of 1.0ml/min (UV detection at 270nm). Linearity was observed over the concentration range of 10-110µg/ml with a regression equation y=88048x + 44524 and having a regression value (R2) of 0.999. The LOD and LOQ values found to be 10ng and 100ng, respectively. No changes found in ruggedness and robustness studies. The percentage of recovery was found to be 95.25% to 101.81%. Validation studies revealed that the method was specific, accurate, precise, reliable, robust, reproducible and suitable for the quantitative analysis in its pharmaceutical formulations.

Simultaneous method development and Validation by HPLC for Capecitabine and Oxaliplatin in mucoadhesive microspheres containing capsules

2021 ◽  
pp. 3365-3370
Author(s):  
Krishna Patel ◽  
Dipti Patel
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Dipotassium Hydrogen Phosphate ◽  
Liquid Chromatographic Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, specific and accurate reversed-phase high performance liquid chromatographic method was developed for the simultaneous determination of Capecitabine and Oxaliplatin, using a Hypersil BDS C18, 150x4.6 mm, 5μ column and a mobile phase composed of 10mM dipotassium hydrogen phosphate+0.1% TEA pH 5.0: Acetonitrile (50:50%v/v). The flow rate was 1.0 ml/min, and the detection wavelength was 245 nm. The injection volume was 20 μL. The retention times of Capecitabine and Oxaliplatin found 4.29 min and 5.52 min, respectively. Linearity was established for Capecitabine and Oxaliplatin in the range of 60-210μg/ml and 20-70 μg/ml, respectively. The percentage recoveries of Capecitabine and Oxaliplatin found to be in the range of 99.1-101.5% and 97.9-99.7 %, respectively. The proposed method validated for precision, accuracy, linearity range, and robustness. This method can successfully be employed for simultaneous quantitative analysis of Capecitabine and Oxaliplatin in the capsule.

Development and Validation of Midostaurin Assay by RP-HPLC Method

2018 ◽  
Vol 11 (6) ◽  
pp. 4318-4322
Author(s):  
Abrar Ahmed ◽  
Tayyaba Mahtab ◽  
Sumaiyya Saleem
Keyword(s):  
Myeloid Leukemia ◽  
High Performance ◽  
Kinase Inhibitor ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

Midostaurin is a multi-targeted protein kinase inhibitor that has been used for the treatment of acute myeloid leukemia.  Here, a rapid and precise reverse phase high-performance liquid chromatographic method has been developed for the validation of midostaurin, in its API form as well as in capsule dosage form. Chromatography was carried out on a X-Bridge C18 (4.6 x 250 mm, 5 µm) column using a mixture of methanol: water (75:25% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 243nm and the retention time of the midostaurin was found to be 3.155. The method produce linear responses in the concentration range of 10-50 µg/mL of midostaurin. The method precision for the determination of assay was below 2.0 % RSD. The LOD and LOQ values obtained were 1.2 µg/mL and 3.8 µg/mL respectively. There were no significant changes observed upon changing chromatographic conditions indicating the method to be robust. Therefore this validated method can be useful in the quality control of bulk and pharmaceutical formulations of midostaurin. 

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF APIXABAN BY RP-HPLC

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (04) ◽  
pp. 76-79
Author(s):  
A. M Kashid ◽  
M. B. Vidhate ◽  
M. R Ingale ◽  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Standard Addition ◽  
High Performance Liquid Chromatographic ◽  
Limit Of Quantification ◽  
Liquid Chromatographic Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, fast and precise high performance liquid chromatographic method is developed and validated for apixaban as per ICH guideline. Chromatographic separation of drugs was performed on a Kromasil C18 column (250 mm x 4.6 mm, 5 μ) with a mobile phase comprising of sodium acetate: acetonitrile in the ratio 50:50 (V/V) at a flow rate of 1 mL/min. The described method was linear over a concentration range of 10-50μg/mL (r2> 0.994) for apixaban. The limit of detection (LOD) was found to be 0.36μg/mL, whereas the limit of quantification (LOQ) was found to be 1.09μg/mL. The recovery was calculated by the standard addition method. The average recovery was found to be 96.87 %. Developed method was found to be simple, accurate, precise and rapid, hence it can be used for quality control of apixaban.

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