scholarly journals Bioanalytical Validatıon and Accurate RP-HPLC Method Development of Triamcinolone: Application to Bioequıvalence Studies

2016 ◽  
Vol 13 (1) ◽  
pp. 38-53 ◽  
Author(s):  
Selvadurai Muralidharan ◽  
Vijayan Venugopal ◽  
Jayaraja Kumar ◽  
Subramani Parasuraman
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Bioanalytical Validation ◽  
Hplc Method Development

RP-HPLC method development for simultaneous determination of the drugs Ramipril and Amlodipine

2012 ◽  
Vol 2 (2) ◽  
pp. 364-367 ◽  
Author(s):  
Saida Naik Dheeravath ◽  
◽  
Kasani Ramadevi ◽  
Zilla Saraswathi ◽  
Dheeravath Maniklal ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Hplc Method Development

RP-HPLC Method Development and Validation for the Estimation of Sacubitril and Valsartan in Pharmaceutical Dosage Form

2021 ◽  
pp. 5797-5802
Author(s):  
G.M. Kadam ◽  
A.L. Puyad ◽  
T.M. Kalyankar
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Content Uniformity ◽  
Phase Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Hplc Method Development

A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

scholarly journals RP-HPLC Method Development and Validation for Cleaning Residue Determination of Tofacitinib Citrate in Tofacitinib Tablets

2021 ◽  
pp. 262-276
Author(s):  
Thaticherla Kaleswararao ◽  
Duvvuri Suryakala
Keyword(s):  
Method Development ◽  
Drug Product ◽  
Hplc Method ◽  
Solution Stability ◽  
Sample Analysis ◽  
Validation Data ◽  
Manufacturing Equipment ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Development And Validation

A novel, Specific, and precise RP-HPLC method was developed to determine the residue content of Tofacitinib citrate left on the surface of equipment used in the manufacturing process. The manufacturing equipment considered in assessment of cleaning has been verified and found the tools assembled to the equipment are made up of Stainless steel, Glass, Teflon and plastic. Hence, these surfaces of manufacturing equipment that come in contact with the drug product during manufacturing are considered for evaluation of the cleaning procedure. By developing and validating an analytical method for residue estimation, the manufacturing equipment can be evaluated for efficient cleaning and to release the manufacturing equipment for further intended use by minimizing the cross contaminations. The stationary phase suited for the well separation of components is CAPCELL PAK C18 150 x 4.6 mm, 3 μm; 0.4 % perchloric acid and acetonitrile in the ratio of 85:15 % v/v is the mobile phase pumped at a flow rate of 1.2 mL/min through the column at temperature of 40 ºC. Each run extended for 10 min as the Tofacitinib peak elutes at RT of 5.2 min. The method has been validated successfully for Specificity, Precision, Linearity, Accuracy, Ruggedness and Filter validation of both rinse and swab methods. The LOD, LOQ concentrations found to be 0.006, 0.019 µg/mL for swab method and 0.03 and 0.1 µg/mL for rinse method respectively. The correlation coefficient is 0.999 and method found linear from LOQ to 500% for swab method and LOQ to 200% for rinse method. Solution stability has been established to ensure the test solution get tested within the stable time (4 Days). Based on the filter validation data, it is concluded that PVDF filter is not suitable for cleaning sample analysis and 2 mL sample should be discarded when 0.45 µm Nylon filter is used for cleaning sample analysis.

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