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. 

scholarly journals Development and Validation of High Performance Liquid Chromatographic Method for Determination of Lamivudine from Pharmaceutical Preparation

2010 ◽  
Vol 7 (1) ◽  
pp. 117-122 ◽  
Author(s):  
S. K. Patro ◽  
S. R. Swain ◽  
V. J. Patro ◽  
N. S. K. Choudhury
Keyword(s):  
High Performance ◽  
Pharmaceutical Preparation ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Tablet Formulations ◽  
Development And Validation ◽  
Liquid Chromatographic

A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of lamivudine in pure and tablet formulations. A Thermo BDS C18 column in isocratic mode, with a mobile phase consisting of 0.01 M ammonium dihydrogen orthophosphate buffer adjusted to pH 2.48 by using formic acid and methanol in the ratio of 50:50 was used. The flow rate was set at 0.6 mL/min and UV detection was carried out at 264 nm. The retention time of lamivudine and nevirapine were 2.825 min and 4.958 min respectively. The method was validated for linearity, precision, robustness and recovery. Linearity for lamivudine was found in the range of 50-175 μg/mL. Hence, it can be applied for routine quality control of lamivudine in bulk and pharmaceutical formulations.

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.

DEVELOPMENT AND VALIDATION OF A NEW RP HPLC METHOD FOR ROUTINE DETERMINATION OF TEA TREE OIL IN BULK AND COSMECEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (07) ◽  
pp. 43-49
Author(s):  
B.P. Manjula ◽  
V. G Joshi ◽  
Siddamsetty Ramachandra Setty ◽  
M Geetha ◽  
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Tea Tree Oil ◽  
Tea Tree ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

Tea tree oil, an active ingredient of skin, hair and nail care cosmeceuticals, has claims for topical antimicrobial, analgesic and anti-inflammatory activity. Its complex composition is governed by ISO 4730:2017. Terpinene-4-ol is the principal constituent of the oil (35% - 48%) followed by γ-terpinene (14% -28%), α-terpinene (6%-12%) and 1,8-cineole (≤15%). A reversed-phase, isocratic high performance liquid chromatographic method has been developed and validated for routine determination of tea tree oil based on1,8-cineole content in bulk and commercially available cosmeceuticals using C18 column, methanol-water (70:30 v/v) as mobile phase and flow rate of 1mL/min. UV detection was done at 200 nm. Linearity of the method was established for 20-100μL/mL (R2 = 0.9992) with LOD, LOQ values of 0.5594 μL/mL and 5.5941μL/mL respectively. The % RSD values for robustness and precision were <1% and recovery ranged between 99.09-102.96%. The method was successfully applied for determination of 1,8-cineole content in cosmeceuticals.

scholarly journals Development and validation for determination of lisinopril dihydrate in bulk drug and formulation using RP-HPLC method

2018 ◽  
Vol 3 (2) ◽  
pp. 14-18
Author(s):  
Zahid Zaheer ◽  
Sarfaraz Khan ◽  
Mohammad Sadeque ◽  
Hundekari G. I. ◽  
Rana Zainuddin
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for Lisinopril in bulk drug and formulation. A column having 150 × 4.6 mm in isocratic mode with mobile phase containing acetonitrile: phosphate buffer (70:30; adjusted to pH 3.0) was used. The flow rate was 0.8 ml/min and effluent was monitored at 216 nm. The retention time (min) and linearity range (μg/ml) for Lisinopril was (1.510) and (10-35). The developed method was found to be accurate, precise and selective for determination of Lisinopril in bulk and formulation.

scholarly journals DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD DETERMINATION OF ZIDOVUDINE ENCAPSULATED IN PCL NANOPARTICLES

2017 ◽  
Vol 1 (2) ◽  
pp. 1-8
Author(s):  
Milena Cristina Ribeiro Souza Magalhães ◽  
Alisson Samuel Portes Caldeira ◽  
Hanna De Sousa Rocha Almeida ◽  
Sílvia Ligório Fialho ◽  
Armando Da Silva Cunha Junior
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of encapsulation efficiency of zidovudine in nanoparticules. The method was carried out in isocratic mode using 0.040M sodium acetate: methanol: acetonitrile: glacial acetic acid (880:100:20:2) as mobile phase, a C8 column at 25ºC and UV detection at 240 nm. The method was linear (r2 ˃ 0.99) over the range of 25.0-150.0 μg/mL, precise (RSD ˂ 5%), accurate (recovery = 100.5%), robust and selective. The validated HPLC-UV method can be successfully applied to determine the rate of zidovudine in nanoparticules.

scholarly journals Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Haloperidol and Trihexyphenidyl in API and Combined Tablet Dosage Form

2018 ◽  
Vol 3 (03) ◽  
pp. 36-40 ◽  
Author(s):  
E. Amulya ◽  
N. Naveen Kumar ◽  
CH. Mounika ◽  
V. Kowmudi ◽  
N. Supriya ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trihexyphenidyl and Haloperidol, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Altima C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 225 nm. The retention time of the Trihexyphenidyl and Haloperidol was 2.102, 3.537±0.02min respectively. The method produce linear responses in the concentration range of 15-75ppm of Trihexyphenidyland 37.5-187.5ppm of Haloperidol. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pharmaceutical formulations.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Gemifloxacin Mesylate in Bulk and Pharmaceutical Dosage Forms

2010 ◽  
Vol 7 (4) ◽  
pp. 1621-1627 ◽  
Author(s):  
Yunoos Mohammad ◽  
B. Pragati Kumar ◽  
Azmath Hussain ◽  
Harish
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, rapid, accurate, precise and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of gemifloxacin mesylate in bulk and pharmaceutical formulations. The quantification was carried out using cyberlab capcell pak, ODS C18(250 × 4.6 mm i.d., 5 μm particle size) column in an isocratic mode, with mobile phase comprising Buffer (KH2PO4with pH 6.8): acetonitrile in the ratio of 80:20 (%v/v).The flow rate was at 1.2 mL/min and the detection was carried out at 265 nm. The retention time of the drug was found to be 7.47 min and the method produced linear response in the concentration range of 25-150 μg/mL (R∼0.99986). The recovery studies were also carried out and % RSD from reproducibility was found to be 0.82. The proposed method was statistically evaluated and can be applied for routine quality control analysis of gemifloxacin mesylate in tablets.

Development and Validation of RP-HPLC method for the Estimation of Ritonavir in API and tablet Formulation

2021 ◽  
pp. 5457-5460
Author(s):  
Avinash Birajdar ◽  
Varsha Tegeli ◽  
Suyash Ingale ◽  
Gajanand Nangare
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

A Reverse Phase High Performance Liquid Chromatographic method has been developed and validated for estimation of Ritonavir in API and Tablet formulation. The chromatographic separation was carried out using ZOROBAX Bonus-RP C-18 column (250 x 4.6mm, 5µm) as stationary phase and Methanol: Acetonitrile: 0.1% Trifluoroacetic acid water (81:9:10) as mobile phase at 1.0 ml/min flow rate and detection was carried out at 250 nm. The method was validated accordance to the Guidelines of International Council for Harmonization (ICH). Ritonavir have linearity in the concentration range of 50-150µg/ml with correlation coefficient (r2=1) respectively. Ritonavir eluted at 3.05 min respectively. The method is sensitive, precise and accurate. So, the method can be successfully applied for the routine analysis of Ritonavir in pharmaceutical formulations.

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