scholarly journals Cleaning method validation for estimation of dipyridamole residue on surface of the drug product manufacturing equipment using the swab sampling and by using high performance liquid chromatographic technique

2019 ◽  
Author(s):  
Sriram Valavala ◽  
Nareshvarma seelam ◽  
Subbaiah Tondepu ◽  
Vivekanandan Sundaramurthy
Keyword(s):  
Method Validation ◽  
High Performance ◽  
Drug Product ◽  
High Performance Liquid Chromatographic ◽  
Chromatographic Technique ◽  
Manufacturing Equipment ◽  
Cleaning Method ◽  
Product Manufacturing ◽  
Liquid Chromatographic

scholarly journals Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

2018 ◽  
Vol 17 (1) ◽  
pp. 123-129
Author(s):  
Sharifa Sultana ◽  
Md Shahadat Hossain ◽  
Md Samiul Islam ◽  
Abu Shara Shamsur Rouf
Keyword(s):  
High Performance ◽  
Drug Product ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Chromatographic Technique ◽  
Pharmaceutical Dosage Form ◽  
Relative Standard ◽  
Liquid Chromatographic

A novel reversed phase ultra-high performance liquid chromatographic (RP-UHPLC) method was developed for the estimation of sitagliptin in pharmaceutical dosage form. Separation was done by a X-bridge C18 column (4.6 i.d.× 150 mm, 5 μm particle size) with a flow rate of 1 ml/min using phosphate buffer (pH 6) and acetonitrile (70:30, v/v) as mobile phase at 268 nm using photodiode array plus (PDA+) detector. The retention time was found at 4.607 min. The developed method was validated as per the requirements of ICH-Q2B guidelines for specificity, system suitability, linearity, precision, accuracy, sensitivity and robustness. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.999 with LOD value of 0.06 μg/ml and LOQ of 0.225 μg/ml. The relative standard deviation (%RSD) for inter-day and intra- day precision was not more than 2.0%. The method was found to be accurate with percentages recovery of 98.50±0.03 to 99.70±0.05 and the % RSD was less than 2. The results showed that the proposed method is highly convenient for routine analysis of sitagliptin.Dhaka Univ. J. Pharm. Sci. 17(1): 123-129, 2018 (June)

scholarly journals Inhibition of prolyl oligopeptidase by flavonoids isolated from the roots of Allexis obanensis (Baker f.) Melch

2021 ◽  
Vol 1 (2) ◽  
pp. 39-44
Author(s):  
Olivier Ndogo Eteme ◽  
Nkwengoua Tchouboun Zondegoumba Ernestine ◽  
Soh Desire ◽  
Oladimeji Taiwo Babatunde ◽  
Barthelemy Nyasse
Keyword(s):  
Neurodegenerative Diseases ◽  
Column Chromatography ◽  
Inhibitory Activity ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Chromatographic Technique ◽  
Carboxy Terminus ◽  
Prolyl Oligopeptidase ◽  
Liquid Chromatographic

Background: Prolyl oligopeptidase is a cytosolic serine peptidase that hydrolyzes peptides containing proline at the carboxy terminus of proline residues. It has been associated with several neurodegenerative diseases. Therefore, it is a target in the management of these disease conditions. Methods: Allexis obanensis was taken through cold extraction, subjected to column chromatography and flavonoids isolated via high-performance liquid chromatographic technique. The flavonoids obtained were investigated for their in vitro prolyl oligopeptidase inhibitory activity. Results: The flavonoids isolated include: 4.4'''- dimethoxylophirone A [1] and 7-hydroxy-3-(3-hydroxy-4 méthoxyphenyl)-5- méthoxy-4H chromen-4-one [2]. They inhibited prolyl oligopeptidase at low IC50 concentrations of 7.201±3.021 µM and 6.223±2.002 µM respectively. Conclusion: The results obtained from this study proves the potential of these flavonoids as prolyl oligopeptidase inhibitors, by inference, their potentiality in the management of neuropsychiatric disorders.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE USING RAPID HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE

2018 ◽  
Vol 11 (11) ◽  
pp. 118
Author(s):  
Zubaidur Rahman ◽  
Vijey Aanandhi M ◽  
Sumithra M
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Sensitivity ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Chromatographic Technique ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2–10 μg/mL with a regression coefficient of 0.9999. The method has proved high sensitivity and specificity.Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of ATH in bulk drug and in its pharmaceutical dosage form.

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