Government College of pharmacy

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF MEBENDAZOLE IN API AND PHARMACEUTICAL FORMULATIONS

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ABOUT AUTHORS
Durgesh Rameshlal Parakh1*, Jayshri K. Madagul1, Harshad Rajendra Mene2, Moreshwar P. Patil1, Sanjay J. Kshirsagar1
1
Department of Pharmaceutics,
MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, India.
2 Department of Pharmaceutics,
Government College of Pharmacy, Osmanpura, Aurangabad, Maharashtra, India.
*aryanparakh57@gmail.com

ABSTRACT
A new simple and sensitive RP-HPLC method was developed and validated for quantification of Mebendazole in Active Pharmaceutical Ingredient (API) and pharmaceutical formulation.The gradient RP-HPLC method was developed on Agilent (India) C18 250 × 4.6 mm, 5 μ column using mobile phase as acetonitrile: water pH 3.0 with orthophosphoric acid (90:10 v/v) at a flow rate of 1 mL/min and detection was carried out at 234 nm using UV-Visible detector (UV 3000 M). The method was validated linearity, limit of detection, limit of quantification, precision, ruggedness, robustness, accuracy and specificity were found to be satisfactory. The method was found to be linear in the concentration range of 20-100 μ/mL with correlation coefficient of 0.999. The method was validated according to the ICH guidelines and was proved to be specific, linear, accurate, precise and economical for the analysis of Mebendazole.

REVIEW:- INDUSTRIAL PROCESS VALIDATION OF TABLET DOSAGE FORM

ABOUT AUTHORS:
1
Abhijeet Welankiwar*, Sushant tope.
1
Government College of pharmacy
kathora naka Amravati (Maharashtra) 444604.
*abhi123welankiwar@gmail.com

ABSTRACT: -
The validation is a Fundamental segment that supports to a commitment of company towards quality assurance. It also assures that product meets its predetermined quality specification and quality characteristics. Validation of individual step of manufacturing is called as process validation. Here this article concerns with the process validation of tablet dosage form which has a numerous advantages over other dosage forms. The objective is to present a review and to discuss aspects of validation in terms of pharmaceutical unit operations; that is, those individual technical operations that comprise the various steps involved in product design and evaluation.