scholarly journals DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF ERDAFITINIB IN MARKETED FORMULATIONS

2020 ◽  
Vol 9 (3) ◽  
Author(s):  
M. Maithani ◽  
D. Dwivedi ◽  
D. Hatwal ◽  
P. Bansal
Keyword(s):  
Mobile Phase ◽  
Pharmaceutical Preparations ◽  
Hplc Method ◽  
Sodium Acetate Buffer ◽  
Rp Hplc ◽  
The Mean ◽  
Uv Visible ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP-HPLC method for the estimation of Erdafitinib in tablet dosage form was developed and validated. The chromatographic separation of the drug was done with a Hypersil™ ODS C18 Column (150 mm × 4.6 mm i.d., particle size 5 μ) using 20mM sodium acetate buffer (pH 4. ±0.02), methanol and acetonitrile (60:10:30 v/v/v) as a mobile phase. The instrument was set at flow rate of 1.0 mLmin-1 at ambient temperature and the wavelength of UV-visible detector at 310nm. The method showed excellent linearity over a range of 5-35 μgmL-1 for the drug. The correlation coefficient for Erdafitinib was noted to be 0.9999. The mean recovery values were found to be 99.77% and 100.88%. The results suggest that the proposed method could be suitable for quantitative determination of Erdafitinib in pharmaceutical preparations and also for quality control in bulk manufacturing. The F-test and t-test at 95% confidence level were applied on data for statistical analysis.

scholarly journals Development and Validation of RP-HPLC Method for Estimation of Amlodipine Besylate and Celecoxib in Pharmaceutical Formulation

2020 ◽  
Vol 10 (6) ◽  
pp. 31-36
Author(s):  
P Nagamani ◽  
SY Manjunath ◽  
T Hemant Kumar
Keyword(s):  
High Performance ◽  
Pharmaceutical Products ◽  
Hplc Method ◽  
Amlodipine Besylate ◽  
Linear Calibration ◽  
Rp Hplc ◽  
Uv Visible ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise, accurate, and rapid reverse phase-high performance liquid chromatography (RP-HPLC) method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of amlodipine besylate(AML) and celecoxib(CEL) in their combined tablet dosage form. The separation was based on the use of a Flowrosil C18   analytical column (250 × 4.6 mm, i.d., 5 µm). The mobile phase consisted of a mixture of 80 volumes of acetonitrile and 20 volumes of water. The chromatography was performed by isocratic elution at a flow rate of 1 mL/min. Analytes were detected at 250 nm, with linear calibration curves at concentration ranges of 2-12 µg/ml and 50-300 µg/ml for AML and CEL respectively. The retention time of AML and CEL were 1.98 and 3.15 min respectively. The recoveries obtained were 99.46‒101.36% for AML, 99.57‒101.42% and 99.96–100.87 % for CEL. The method was validated according to International conference of harmonisation guidelines in terms of accuracy, precision, specificity, robustness, limits of detection and quantitation, and other aspects of analytical validation. The developed method was applied successfully for HPLC analysis of commercial pharmaceutical products including AML and CEL. Keywords: Amlodipine besylate; Celecoxib; RP-HPLC.

RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND OMEPRAZOLE IN BINARY COMBINATION

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (08) ◽  
pp. 38-43
Author(s):  
A. M Kashid ◽  
◽  
S. V. Tathe ◽  
S. G. Sahoo ◽  
A. B. Ghatge ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Sodium Acetate Buffer ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision Study ◽  
The Mean

A simple, accurate, rapid and precise RP-HPLC method for the simultaneous estimation of aspirin and Omeprazole in binary mixture has been developed and validated. The drugs were resolved using HPLC column (ACE 250 x 4.6 mm C18 column) with mobile phase of HPLC grade methanol: Sodium acetate buffer (70:30 v/v) at a flow rate of 1 mL/min. The retention times of aspirin and omeprazole were 3.10 ± 0.3min and 5.01 ± 0.02min with UV detection at 230 nm. The method was validated with respect to linearity, sensitivity, accuracy, precision and robustness as per the International Conference on Harmonization (ICH) guidelines. The method was specific and it was observed that no interference with diluents. The linearity was established over the concentration range of 40-140μg/ml and 20-120μg/mL with correlation coefficients (r2) 0.9998 and 0.9986 for aspirin andomeprazole magnesium respectively. The mean recoveries were found to be in the range of 97.05%-99.75% and 97.21% -98.76% for aspirin and omeprazole respectively. The % R.S.D. values for intra-day precision study and inter-day study were <1.0%, confirming that the method is precise. The method can be successfully employed for the simultaneous determination of aspirin and omeprazole.

RP-HPLC AND HPTLC STABILITY INDICATING ASSAY METHODS FOR IVERMECTIN IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (03) ◽  
pp. 32-42
Author(s):  
G. P Wani ◽  
◽  
S. B Jadhav
Keyword(s):  
Mobile Phase ◽  
Stress Testing ◽  
Hplc Method ◽  
Rp Hplc ◽  
Assay Methods ◽  
Photo Stability ◽  
Tablet Dosage ◽  
Hptlc Method ◽  
Alkaline Oxidation

Simple, rapid, precise, accurate RP-HPLC and HPTLC methods have been developed and validated for ivermectin in bulk and its marketed formulation. RP-HPLC method for drug was achieved on Grace C18 (250 mm X 4.6 ID, Particle size; 5 μ) column using mobile phase acetonitrile: 10 mM phosphate buffer (95:05 v/v) pH adjusted to 3 with o-phosphoric acid. Detection of drug was done at 245 nm. The retention time was found to be 5.83 min. HPTLC method for ivermectin was accomplished on a precoated silica gel aluminium plate 60F-254 (CAMAG Linomat 5), using toluene: methanol: glacial acetic acid (8:2:0.1 v/v/v) as a mobile phase. The densitometric scanning was performed at 245 nm which showed Rf 0.46 for ivermectin. The stress testing of the drug individually was carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions. The proposed methods were successfully applied for the determination of drug in bulk and its marketed formulation.

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF BERBERINE AND CURCUMIN IN AN AYURVEDIC FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (08) ◽  
pp. 48-52
Author(s):  
K. P Parekh ◽  
◽  
A. P. Jadhav
Keyword(s):  
Mobile Phase ◽  
Herbal Medicines ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Quality And Safety ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Water Ph ◽  
Development And Validation

A simple, accurate, precise, robust stability indicating RP-HPLC method was developed and validated for simultaneous estimation of berberine and curcumin in an ayurvedic formulation. The two markers were resolved using a C-18 column using as the mobile phase methanol: water (pH 3 adjusted using acetic acid) in the ratio 75:25 V/V at a flow rate of 1mL/min. Retention times of berberine and curcumin were 2.58 ± 0.2 min and 8.5 ± 0.2 min, respectively at 358 nm. Linear response was observed in the concentration range of 2 – 8 ppm for berberine and 5 – 40 ppm for curcumin, with correlation coefficient (r2) of 0.994 and 0.998 for berberine and curcumin, respectively. The developed method was applied for quantitation of markers in marketed and in-house formulations of Gruhadhoomadi Churna. This method can also be used to evaluate formulations containing berberine and curcumin as markers, thus conforming to the need of ensuring quality and safety of herbal medicines.

scholarly journals Development and validation of RP-HPLC method for determination of Atorvastatin calcium and Nicotinic acid in combined tablet dosage form

2016 ◽  
Vol 20 ◽  
pp. S328-S333 ◽  
Author(s):  
Jaiprakash N. Sangshetti ◽  
Mohammed Aqeel ◽  
Zahid Zaheer ◽  
Rana Z. Ahmed ◽  
M.H.G. Dehghan ◽  
...  
Keyword(s):  
Nicotinic Acid ◽  
Dosage Form ◽  
Hplc Method ◽  
Atorvastatin Calcium ◽  
Rp Hplc ◽  
Development And Validation ◽  
Tablet Dosage

scholarly journals Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

scholarly journals Determination of Mefenamic Acid in Pharmaceutical Drugs and Wastewater by RP-HPLC

2017 ◽  
Vol 2 (2) ◽  
pp. 85-88
Author(s):  
Mohammad Anas Alfeen
Keyword(s):  
Mefenamic Acid ◽  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Pharmaceutical Preparations ◽  
Hplc Method ◽  
Treated Wastewater ◽  
Pharmaceutical Drugs ◽  
Analysis Method ◽  
Rp Hplc

This study presents a chromatographic analysis method for the determination of mefenamic acid in pharmaceutical preparations and treated wastewater from the pharmaceutical industry in East Asia and specifically (Syria). An isocratic RP-HPLC method has been developed for determination of Mefenamic acid on a Grace, alltima C18 column (250 x 4.6 mm, 5.0 μm) using a mobile phase consisting of (1%) Triethylamine aqueous buffer adjust pH = 2 by H3PO4 (85%): Methanol: Acetonitrile); (35: 20: 45 v\v\v %) at a flow rate of 2 mL/min. Detection was carried out at 220 nm. Retention time of Mefenamic acid was 7.85 ( ± 0.36) mins. The method was validated with respect to specificity, linearity, accuracy, precision, ruggedness, and robustness.  The proposed method is simple, precise, sensitive, and reproducible and is applicable for quantification of Mefenamic acid in Tablets formulations and Wastewater developed and formulated in our laboratory.

scholarly journals Development and Validation of RP-HPLC for Estimation of Neratinib in Bulk and Tablet Dosage Form

2019 ◽  
Vol 11 (02) ◽  
Author(s):  
M Lakshmi Kanth ◽  
B Raj Kama
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Chromatographic Separation ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Rp Hplc ◽  
Monopotassium Phosphate ◽  
Development And Validation ◽  
Tablet Dosage

An accurate RP-HPLC method developed for the estimation of Neratinib in bulk and tablet dosage form. The method is and validated for parameters linearity, accuracy, suitability, specificity, precession, LOD, LOQ and robustness. An Altima column (150 mm × 4.6 mm × 5μ) used for chromatographic separation within a runtime of 6 min. The mobile phase buffer (monopotassium phosphate) and acetonitrile (60:40 v/v) with 0.1% formic acid is used. The flow rate maintained at 1.0 ml/min with the effluents monitored at 215 nm. The Neratinib analyzed at retention time of 4.001. The concentration linear over 30-180μg/ml with regression equation y = 6065.6x + 795.43 and regression co-efficient 0.999.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

Sign in / Sign up

Export Citation Format

Share Document