scholarly journals High Pressure Liquid Chromatographic Method for the Determination of Mobocertinib in Pharmaceutical Dosage Form and Study of Its Degradation

2021 ◽  
pp. 154-162
Author(s):  
Gunturu. Raviteja ◽  
Kantipudi Rambabu
Keyword(s):  
Wave Length ◽  
High Pressure Liquid Chromatographic ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Formulation Analysis ◽  
College Of Engineering ◽  
Liquid Chromatographic ◽  
Mathematical Process

Aims: New validated method for the estimation of Mobocertinib using HPLC and study of its degradation. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an X-bridge phenyl column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (60:40 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 224 nm. Mobocertinib had a retention time of 2.271 minutes. The isocratic chromatography was performed at room temperature and took approximately five minutes to complete. Results: Analysis was achieved within 5 min over an honest linearity within the concentration range from 6-90 µg/ml of Mobocertinib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.075μg/ml and 0.248 g/ml for Mobocertinib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.

scholarly journals Stability Demonstrating Validated High Pressure Liquid Chromatographic Method for the Determination of Trilaciclib in Bulk and Pharmaceutical Formulation

2021 ◽  
pp. 173-181
Author(s):  
Syed. Rafi ◽  
Kantipudi Rambabu
Keyword(s):  
Andhra Pradesh ◽  
Wave Length ◽  
High Pressure Liquid Chromatographic ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Formulation Analysis ◽  
College Of Engineering ◽  
Liquid Chromatographic ◽  
Mathematical Process

Aims: New validated method for the estimation of  Trilaciclib using HPLC and study of its degradation Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an inertsil ODS column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (50:50 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 220 nm. Trilaciclib had a retention time of 4.358 minutes. The isocratic chromatography was performed at room temperature and took approximately six minutes to complete. Results: Analysis was achieved within 6 min over an honest linearity within the concentration range from 3-45 µg/ml of Trilaciclib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.038 μg/ml and 0.124 g/ml for trilaciclib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.

scholarly journals A Rapid Determination of Cinnarizine in Bulk and Pharmaceutical Dosage Form by LC

2010 ◽  
Vol 7 (3) ◽  
pp. 1080-1084 ◽  
Author(s):  
A. A. Heda ◽  
A. R. Sonawane ◽  
G. H. Naranje ◽  
P. K. Puranik
Keyword(s):  
Potassium Hydroxide ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Rapid Determination ◽  
High Pressure Liquid Chromatographic ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic

A simple, selective, rapid and precise reverse phase high pressure liquid chromatographic method has been developed for the estimation of cinnarizine from pharmaceutical formulation. The method was developed using MICRA-NPS C18(length×OD×ID =33×8.0×6.0 mm, 1.5 μm) column with a mobile phase consisting of acetonitrile, triethylamine buffer (adjusted to pH 4.5 with 10% w/v potassium hydroxide) and tetrahydrofuran in the ratio 30:66:4 respectively, at a flow rate of 0.5 mL/min. Wavelength was fixed at 253 nm. The developed method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation. The proposed method can be used for the routine estimation of cinnarizine in pharmaceutical dosage form.

A Versatile Stability-indicating Liquid Chromatographic Method for the Simultaneous Determination of Atenolol, Hydrochlorothiazide and Chlorthalidone

2020 ◽  
Vol 16 (8) ◽  
pp. 1037-1051
Author(s):  
Ehab Farouk Elkady ◽  
Marwa Ahmed Fouad ◽  
Abdulgabar A. Ezzy Faquih
Keyword(s):  
Quality Control ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Pharmaceutical Dosage Forms ◽  
Potassium Dihydrogen ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic ◽  
Potassium Dihydrogen Orthophosphate

Background: Atenolol is a selective beta 1 blocker that can be used alone or in combination with hydrochlorothiazide or with chlorthalidone for the treatment of hypertension and prevention from a heart attack. Objective: The main target of this work was to improve modern, easy, accurate and selective liquid chromatographic method (RP-HPLC) for the determination of these drugs in the presence of their degradation products. These methods can be used as analytical gadgets in quality control laboratories for a routine examination. Methods: In this method, the separation was accomplished through an Inertsil® ODS-3V C18 column (250 mm x 4.6 mm, 5 μm), the mobile phase used was 25 mM aqueous potassium dihydrogen orthophosphate solution adjusted to pH 6.8 by using 0.1M sodium hydroxide and acetonitrile (77 : 23, v/v), the flow rate used was 1 ml/min and detection was achieved at 235 nm using UV. Results: All peaks were sharp and well separated, the retention times were atenolol degradation (ATN Deg.) 2.311 min, atenolol (ATN) 2.580 min, hydrochlorothiazide degradation (HCT Deg.) 5.890 min, hydrochlorothiazide (HCT) 7.016 min, chlorthalidone degradation CTD Deg 8.018 min and chlorthalidone (CTD) 14.972 min. Linearity was obtained and the range of concentrations was 20- 160 μg/ml for atenolol, 10-80 μg/ml for hydrochlorothiazide and 10-80 μg/ml for chlorthalidone. According to ICH guidelines, method validation was accomplished, these methods include linearity, accuracy, selectivity, precision and robustness. Conclusion: The optimized method demonstrated to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

Optimized liquid-chromatographic determination of metronidazole and its metabolites in plasma.

1984 ◽  
Vol 30 (5) ◽  
pp. 784-787 ◽  
Author(s):  
R A Gibson ◽  
L Lattanzio ◽  
H McGee
Keyword(s):  
Rapid Determination ◽  
Chromatographic Determination ◽  
Reversed Phase ◽  
Detector Response ◽  
High Pressure Liquid Chromatographic ◽  
Liquid Chromatographic Method ◽  
Wide Range ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic

Abstract Metronidazole and its known metabolites in plasma can be rapidly separated by a "high-pressure" liquid-chromatographic method that can also be adapted for rapid determination of tinidazole. Samples deproteinized with trichloroacetic acid (50 g/L final concentration) undergo isocratic separation on a reversed-phase C18 column eluted with an 8/92 (by vol) mixture of acetonitrile/KH2PO4 (5 mmol/L, pH 3.0). The method is sensitive, reliably detecting as little as 25 micrograms of metronidazole and (or) its metabolites per milliliter of plasma. The detector response varied linearly with concentration for all compounds tested over a wide range (25-500 micrograms/L). Within-day and between-day variation was generally less than 2.5% for all concentrations of all compounds tested. Various other antibiotics tested did not interfere.

scholarly journals Liquid Chromatographic Method for the Analysis of Brimonidine in Ophthalmic Formulations

2012 ◽  
Vol 9 (3) ◽  
pp. 1327-1331 ◽  
Author(s):  
A. Narendra ◽  
D. Deepika ◽  
M. Mathrusri Annapurna
Keyword(s):  
Limit Of Detection ◽  
Detector Response ◽  
Eye Drops ◽  
Reverse Phase ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Acid Sodium Salt ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A reverse phase LC method was developed for the determination of Brimonidine in eye drops. Chromatography was carried on an Inertsil ODS 3V column (C18) using a mixture of Octane 1- sulfonic acid sodium salt (0.02M) (pH 3.5 ± 0.05) and acetonitrile (64:36 v/v) as mobile phase at a flow rate of 1 mL/min with UV detection at 254 nm. The drug was eluted at 4.636 min. The detector response was linear in the concentration range of 0.4–72 μg/mL. The limit of detection and limit of quantification were found to be 0.0561 and 0.1848 μg/mL respectively. The proposed method was validated as per the ICH guidelines and can be applied for the routine analysis of Brimonidine in eye drops.

Ion Pairing High Pressure Liquid Chromatographic Determination of Amaranth in Licorice Products

1981 ◽  
Vol 64 (6) ◽  
pp. 1411-1413
Author(s):  
William J Hurst ◽  
James M Mckim ◽  
Robert A Martin
Keyword(s):  
High Pressure ◽  
Ion Pairing ◽  
Chromatographic Determination ◽  
Buffer Solution ◽  
High Pressure Liquid Chromatographic ◽  
Coefficients Of Variation ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic

Abstract A high pressure liquid chromatographic method is described for the determination of amaranth (FD&C Red No. 2; Red No. 2) in licorice products. The Red No. 2 is extracted with a basic buffer solution, cleaned up on a Sep-Pak column, chromatographed on a reverse phase column in the ion pairing mode, and detected at 254 nm. The procedure is time-conservative with accurate and precise results. Recovery data ranged from 93 to 104%, and coefficients of variation were less than 4% for standards and samples.

Determination of Uncombined Intermediates in FD&C Yellow No. 6 by High-Pressure Liquid Chromatography

1974 ◽  
Vol 57 (2) ◽  
pp. 358-359
Author(s):  
Manjeet Singh
Keyword(s):  
High Pressure ◽  
Chromatographic Method ◽  
Sulfanilic Acid ◽  
Sunset Yellow ◽  
High Pressure Liquid Chromatographic ◽  
Liquid Chromatographic Method ◽  
Two Samples ◽  
Liquid Chromatographic ◽  
Good Agreement

Abstract A high-pressure liquid chromatographic method is presented for the isolation and determination of uncombined intermediates in FD&C Yellow No. 6 (sunset yellow FCF, CI. No. 15895). Samples of FD&C Yellow No. 6 containing 0.1-0.4% sulfanilic acid, 0.1-0.4% 6-hydroxy-2-naphthalenesulfonic acid, and 0.3— 1.0% 6,6'-oxybis(2-naphthalenesulfonic acid) were prepared and analyzed using this method. Recoveries ranged between 94 and 101%. Twenty-two samples of FD&C Yellow No. 6 were analyzed by the conventional column elution chromatographic method as well as by the high-pressure liquid chromatographic method. Good agreement was obtained between the 2 methods.

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