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

Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

2021 ◽  
pp. 73-78
Author(s):  
Anupam Sharma ◽  
Amar Deep Ankalgi ◽  
Arti Devi ◽  
Vinay Pandit ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Chromatographic Procedure ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation

A rapid isocratic chromatographic procedure for the analysis of methotrexate, hydroxychloroquine sulfate in bulk drug and pharmaceutical formulations was developed validated in the present study. The mobile phase consists of a mixture of Water: Acetonitrile: Tetrahydrofuran in the proportion of 50:40:10 and pH maintained to 3with perchloric acid. Retention time was found to be 3.0 and 3.7minutes for methotrexate and hydroxychloroquine sulfate respectively. The method was performing by using the C18 column, ODS Hypersil column with UV detection at 318nm, and flow rate of 1.0ml/min. The percentage of recovery for both drugs was found to be 99.99%. All validation parameters were within limits as per the ICH guidelines.

scholarly journals STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC

2020 ◽  
pp. 307-318
Author(s):  
RowthulaPrasanna Surya Bhavani RowthulaPrasanna Surya Bhavani ◽  
M.Sandhya Maduri M.Sandhya Maduri
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage

A new, simple, precise, accurate, and reproducible RP-HPLC for stability-indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation ofLedipasvir and Sofosbuvir was successfully achieved Dona Zorbax C8, 250 X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and the eluate was monitored at 238nm, with a retention time of 3.303 and 7.303minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45µg/ml to135 µg/ml for Ledipasvirand 200µg/ml to 600 µg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvirand 1 for Sofosbuvir respectively. The LOQ for Ledipasvirwere found to be  0.695 respectively. The LOQ for Sofosbuvir was found to be 2.2063 respectively. This method was found to be a good percentage recovery for Ledipasvir and Sofosbuvirwere found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from the excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity, and Robustness.

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.

Method Development and Validation of Canagliflozin by using RP-HPLC in Pure and Tablet Dosage Form

2021 ◽  
pp. 209-212
Author(s):  
Swapna Singh ◽  
Prem Kumar Bichala ◽  
Abhishek Agrawal
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Intermediate Precision ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Column Flow Rate

A new method was established for simultaneous estimation of Canagliflozin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Canagliflozin by using INERTSIL column, C18 (150x4.6)5µm column, flow rate was 1ml/min, mobile phase ratio was Water: Acetonitrile (70:30), detection wavelength was 264nm. The instrument used was Hitachi HPLC Auto Sampler, Separation module 1575. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Canagliflozin was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, %mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, %RSD for intermediate precision was 0.5 and 0.1 respectively.

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 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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