Asian Journal of Research in Chemistry

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Optimization and Establishment of Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Mefenamic Acid and Paracetamol from Tablet Dosage form


Affiliations
1 Department of Pharmaceutical Analysis, Prin K.M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaokar Marg, Cuffe Parade, Colaba, Mumbai-400 005
     

   Subscribe/Renew Journal


A simple, selective and precise gradient HPLC method has been developed for simultaneous estimation of Mefenamic acid and Paracetamol combination from pharmaceutical dosage form. The separation was accomplished on an HiQSil reversed phase C18 column, 250 mm ×4.6mm I.D., 5µm column using two mobile phases i.e. A as methanol: 50mM potassium dihydrogen orthophosphate (pH = 7.5)(20:80 v/v) and B as methanol in a gradient elution mode. The flow rate was 1mL/min. The eluents were monitored with a UV detector set at 245 nm as detection wavelength. The investigated validation elements showed the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity. Detection and quantification limits were established at 0.02 µg/ml and 0.05 µg/ml respectively. A stability indicating HPLC method has been established for analysis of Mefenamic acid and Paracetamol combination. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal decomposition.

Keywords

Mefenamic Acid, Paracetamol, Gradient Elution, Stability Indicating Method, HPLC
Subscription Login to verify subscription
User
Notifications
Font Size


  • Maryadele J.O; Patricia E.H, Cherie B.K., Kristin J.R., Catherine M.K., Maryann R.D. The Merck index.14th edition .United states Pharmaceutical Company Merck & co.2006, 5798 page no.1001.

  • Sean Sweetman, Martindale: The complete Drug Reference, 36th Edition, Page no.80.

  • Pringsheim T, Davenport WJ, Dodick D. Acute treatment and prevention of menstrually related migraine headache: evidencebased review. Neurology. 2008;70(17):1555-1563.

  • Sean Sweetman, Martindale: The complete Drug Reference, 36th Edition, Page no.108.

  • Hinz, B.; Cheremina, O.; Brune, K. (2008). The FASEB J. Federation of American Societies for Experimental Biology 22 (2): 383–390.

  • K.D. Tripathi, “Essentials of Medical pharmacology, 6th-edition 2008.Page No.198-199

  • Erdal Dinc¸ Cem Yu¨cesoy, Feyyaz Onur,. J. of Pharm. Biomed. Anal, 28(2002)1091-1100.

  • Ali Babaei, Balal Khalilzadeh • Mohammad Afrasiabi, J Appl Electrochem (2010) 40:1537–1543.

  • P.D. Sethi. “Quantitative Analysis of Drug in Pharmaceutical Formulation” 2001 Page No. 390-391.

  • Harish L. Rau, A.R. Arora and P. Gundu Rao. Indian Drugs, 28(12) 563-565,1991.

  • ICH Guidelines: Validation of Analytical Procedures: Test and Methodology, Q2(R1), (2005).


Abstract Views: 919

PDF Views: 2




  • Optimization and Establishment of Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Mefenamic Acid and Paracetamol from Tablet Dosage form

Abstract Views: 919  |  PDF Views: 2

Authors

Sudesh D. Shambharkar
Department of Pharmaceutical Analysis, Prin K.M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaokar Marg, Cuffe Parade, Colaba, Mumbai-400 005
Purnima D. Hamrapurkar
Department of Pharmaceutical Analysis, Prin K.M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaokar Marg, Cuffe Parade, Colaba, Mumbai-400 005

Abstract


A simple, selective and precise gradient HPLC method has been developed for simultaneous estimation of Mefenamic acid and Paracetamol combination from pharmaceutical dosage form. The separation was accomplished on an HiQSil reversed phase C18 column, 250 mm ×4.6mm I.D., 5µm column using two mobile phases i.e. A as methanol: 50mM potassium dihydrogen orthophosphate (pH = 7.5)(20:80 v/v) and B as methanol in a gradient elution mode. The flow rate was 1mL/min. The eluents were monitored with a UV detector set at 245 nm as detection wavelength. The investigated validation elements showed the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity. Detection and quantification limits were established at 0.02 µg/ml and 0.05 µg/ml respectively. A stability indicating HPLC method has been established for analysis of Mefenamic acid and Paracetamol combination. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal decomposition.

Keywords


Mefenamic Acid, Paracetamol, Gradient Elution, Stability Indicating Method, HPLC

References