scholarly journals UV Spectroscopy Assay Method Development and Validation of Dimethyl Fumarate and Cyclosporine Drugs in Nano Dosage Forms

2020 ◽  
Vol 11 (01) ◽  
pp. 196-204
Author(s):  
Deepa Patel ◽  
Sneha Patel ◽  
Drashti Pathak
Keyword(s):  
Method Development ◽  
Uv Spectroscopy ◽  
Dimethyl Fumarate ◽  
Dosage Forms ◽  
Spectroscopic Technique ◽  
Assay Method ◽  
System Suitability ◽  
Line Equation ◽  
Method Development And Validation ◽  
Development And Validation

An easy, precise and accurate spectroscopic technique for the estimation of cyclosporine and dimethylfumarate in pure form and nano dosage form has been developed. The proposed method involves dissolving dimethylfumarate in distilled water and cyclosporine in ethanol and subjecting resulting solution to UV spectroscopic assessment. Absorption maximum was found 210 and 214 nm respectively. Beer’s law was obeyed in the concentration range of 1 to 5and 1 to 8 μg/mL for dimethylfumarate and cyclosporine. Calibration curve showd linearity between absorbance and concentration as per line equation with R2 value near 1. Validation was performed as ICH guildelines for linearity, accuracy, precision, Robustness, System suitability.

Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy

2021 ◽  
pp. 123-126
Author(s):  
Shaik Bima Benazir ◽  
Archana Jorige ◽  
Sumakanth Mogili
Keyword(s):  
Calibration Curve ◽  
Dosage Form ◽  
Method Development ◽  
Uv Spectroscopy ◽  
Dosage Forms ◽  
Simple Method ◽  
Pharmaceutical Dosage Form ◽  
International Conference ◽  
Method Development And Validation ◽  
Development And Validation

A rapid and simple method of spectrophotometric estimation Empagliflozin in UV-region was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The standard and sample solutions were prepared using ethanol and water. The maximum absorbance (λmax) was obtained at 223 nm. The calibration curve was linear in the range of 1-30µg/ml. The %RSD for intra and inter-day precision was found to be 0.29 and 0.39 respectively. Recovery studies of Empagliflozin were within 99.20% to 99.49 and assay was found to be 99.87% and LOD and LOQ was found to be 0.10 and 0.33 respectively. The %RSD for robustness was found to be between 0.20 and %RSD for ruggedness was found to be 0.03. The proposed method was found to be rapid, precise, accurate and can be adaptable for routine analysis of Empagliflozin bulk and marketed dosage forms.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

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