Method Development and Validation for the Simultaneous Analysis of Duloxetine HCL and Methylcobalamine by RP-HPLC

2018 ◽  
Vol 9 (4) ◽  
Author(s):  
Anand Kumar Chettupalli ◽  
Gouthami Thumma ◽  
Narender Boggula ◽  
Vasudha B
Keyword(s):  
Method Development ◽  
Orthophosphoric Acid ◽  
Wave Length ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

A simple, accurate and precise method for simultaneous estimation of Methylcobalamin and Duloxetine by RP-HPLC method has been developed. The chromatographic conditions were successfully developed by using inertsil ODS C18 5��m (4.6*250mm) column, the flow rate was 1ml/min, the mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (30:70%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The retention times were found to be 3.594 min and 5.328 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). T h e suggested RP-HPLC method can be used for routine analysis of Methylcobalamin and Duloxetine in API and Pharmaceutical dosage form.

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.

scholarly journals Method development and validation for simultaneous estimation of methotrexate and curcumin in Bulk Drug by using RP-HPLC

2019 ◽  
Vol 9 (6-s) ◽  
pp. 127-135
Author(s):  
Amar Deep Ankalgi ◽  
Nitin Kumar Chaudhary ◽  
Pooja Kaushal ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Economic Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Natural Herb ◽  
Development And Validation

Curcumin is the natural herb that shows effect in the treatment of cancer and rheumatoid arthritis and methotrexate is well known anticancer and anti-rheumatoid drug. Literature survey reveals that there was no method available for the selected drug combination. So, here an attempt has been made to develop simple, rapid and economic method for simultaneous estimation of methotrexate and curcumin in bulk drug by using RP-HPLC method. The percentage assay from optimized method was found to be 99.68% and 99.76% for methotrexate and curcumin respectively.  The proposed method was validated for  linearity, accuracy, precision and robustness according to ICH guidelines and were found to be   within the standard range. Keywords: RP- HPLC, methotrexate, Linearity, anticancer

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