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.

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

scholarly journals Stability indicating method development and validation for simultaneous estimation and quantification of Ertugliflozin and Metformin in bulk and tablet dosage form

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Bhawani Sunkara ◽  
Tulja Rani Gampa ◽  
Mounika Markanti ◽  
Ratna Kumari Midthapally
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Simultaneous Estimation ◽  
Elution Time ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Simultaneous Evaluation ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

Abstract Background A simple, economical, sensitive, authentic, and faithful technique was used for the study of simultaneous evaluation of Ertugliflozin and Metformin in tablet dosage forms. The Chromatographic analysis was performed isocratically by using a Phenomenex C18 column (150 mm × 4.6 mm, 5 μm), and a mobile phase containing acetonitrile and 0.1% OPA buffer, with a proportion of 40: 60% v/v was passed throughout the column maintained at a temperature of 30 °C with a flow rate of 1 ml/min. Approximately, 10 μl of drug solution was injected and the analytes were eluted at 220.0 nm. Results The elution times of Ertugliflozin and Metformin were 2.226 min and 2.955 min, respectively. The percentage RSD of Ertugliflozin and Metformin are 0.60 and 0.59, respectively. The percentage recoveries of Ertugliflozin and Metformin were determined to be 100.55% and 99.40%, respectively. LOD, LOQ values of Metformin and Ertugliflozin obtained were found to be 0.10, 0.2 μg/ml and 0.03, 0.09 μg/ml, respectively. Regression equation of Ertugliflozin was y = 11287x + 1191 and y = 46270x + 161.0 for Metformin. All verification parameters are within the range according to the ICH guidelines, and the degradation products are also within the limits, which show that the method is stable. Conclusion In the currently developed RP-HPLC analytical method, the elution time and run time is reduced, which proves that the method is economical and widely acceptable, also simple and practical, which can be used in routine quality control tests in the industry.

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 determination of haloperidol and benzhexol by RP-HPLC

2019 ◽  
Vol 1 (2) ◽  
pp. 52-58 ◽  
Author(s):  
M. Syamala ◽  
S Angalaparameswari ◽  
T. VimalakKannan ◽  
C. Sumanjali ◽  
T. Jyotshna
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Haloperidol and Benzhexol in Tablet dosage form. The chromatogram was run through Kromasil (250mm 4.6mm, 5µ). Mobile phase containing Buffer and Acetonitrile and methanol in the ratio of 48:52 was pumped through column at a flow rate of 1.0 ml/min. The temperature was maintained at 30°C. The optimized wavelength for Haloperidol and Benzhexol was 220nm. The retention time of Haloperidol and Benzhexol were found to be 2.415 min and 2.820min. %RSD of the Haloperidol and Benzhexol were and found to be 0.6 and 0.2 respectively. %Recover was Obtained as 98.92% and 99.60% for Haloperidol and Benzhexol. LOD, LOQ values were obtained from regression equations of Haloperidol and Benzhexol were 0.42ppm, 1.27ppm and 0.04ppm, 0.14ppm respectively. Regression equation of Haloperidol is y = 24009x + 38704, and of Benzhexol is y = 40558x + 2880. Retention times are decreased and that run time was decreased so the method developed was simple and economical that can be adopted in regular Quality control test in Industries

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.

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