Method development and validation for multi-component analysis of lamivudine & tenofovir disoproxil fumarate in bulk drug by UV-visible spectrophotometer & RP-HPLC

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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RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations

E-Journal of Chemistry ◽

10.1155/2012/692424 ◽

2012 ◽

Vol 9 (1) ◽

pp. 35-42 ◽

Cited By ~ 1

Author(s):

A. Patnaik ◽

S. S. Panda ◽

S. Sahoo ◽

V. J. Patro

Keyword(s):

Method Development ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Rp Hplc ◽

Method Development And Validation ◽

Uv Visible ◽

Hplc Method Development ◽

Development And Validation ◽

Tablet Dosage ◽

Quantitative Hplc

A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute), wavelength (222 nm) and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug. By using the method, stability of the drug has been studied.

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

Asian Journal of Pharmaceutical Analysis ◽

10.52711/2231-5675.2021.00014 ◽

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.

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A Novel RP-HPLC Method Development and Validation for Estimation of Nicoumalone in Bulk drug and Formulation

Indian Journal of Pharmaceutical Education and Research ◽

10.5530/ijper.50.3.13 ◽

2016 ◽

Vol 50 (3) ◽

pp. 403-408 ◽

Cited By ~ 1

Author(s):

Thota Anusha ◽

Thota Prasad ◽

Valluri Asha Ranjani ◽

Sahu Puranlal ◽

Kumar Robin ◽

...

Keyword(s):

Method Development ◽

Hplc Method ◽

Rp Hplc ◽

Method Development And Validation ◽

Bulk Drug ◽

Hplc Method Development ◽

Development And Validation

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

World Journal of Current Medical and Pharmaceutical Research ◽

10.37022/wjcmpr.vi.159 ◽

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.

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