scholarly journals Novel Method development and Validation of Bortezomib in Bulk and Pharmaceutical dosage form by RP- HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 17-21
Author(s):  
Pasupuleti Laxmi Prasanna ◽  
Pedapanga Sandhya ◽  
Pittala Geetha ◽  
Vallapatla M Anuhya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Wave Length ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

A simple, rapid, precise and accurate RP-HPLC method was developed and validated for the determination of Bortezomib, in bulk and pharmaceutical dosage form. The separation is achieved on RP-HPLC using a PDA detector by incorporation of enpower 2 software with a flow rate of 1.0ml/min using a mixture of Methanol and water (15:85% v/v) as mobile phase. The column used was Hypersil C18 (4.6×150mm, 5µ) at a wave length of 284nm. The retention time of the Bortezomib was 3.515min.. The linearity of the drug was 25-125µg/m and the method precision for the determination of assay was below 2.0% RSD. The proposed method was validated and applied for the estimation of Bortezomib in quality control of bulk and pharmaceutical dosage forms. Keywords: Bortezomib, RP-HPLC, validation.

Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC

2021 ◽  
pp. 84-86
Author(s):  
Abhishek Agrawal ◽  
Prem Kumar Bichala ◽  
Swapna Singh
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Laboratory ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.

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