Journal of Pharmaceutical Research

P. N. Sanjay Pai ¹

Affiliations
1 Goa College of Pharmacy, 18th June Road, Panaji, Goa-403 001, IN

Abstract

Interaction of industries with knowledge base of academic science is important for development of advancement of technology. But what is currently lacking is the willingness from both sides to understand and respect each other's core objectives. Academia need to appoint man-power on war footing that could take Collaborative modes like Consultancy, Contract research, Public - private partnerships in a big way especially in their institutions. Academia need to educate highly trained, independent scientists and to carefully align and integrate their education with ground breaking fundamental research. Industry on the other hand should support the research in the academic institutions through innovation and practical use of advanced technologies. Unfortunately, instead of identifying price-less talent in the industry and making efforts in getting them into academia, the colleges have always believed in utilizing the industry facility at their cost and never ever keen in drawing the ideas and innovations into the academic departments. It is academia's failure in recognizing and accommodating the industry expertise that is preventing the growth of advances in knowledge base as well as technology know how. Constant friction in personalities and also the ideas is bringing no benefits to either side although academia is losing heavily in the process.

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Neelam Sawant ¹, P. N. Sanjay Pai ²

Affiliations
1 Department of Pharmaceutical Analysis (Quality Assurance Group), Goa College of Pharmacy, 18th June Road, Panjim-403001, Goa, IN
2 Department of Pharmaceutical Analysis (Quality Assurance Group), Goa College of Pharmacy, 18th June Road, Panjim-403001, Goa, IN

Abstract

Purpose : A new stability-indicating RP-HPLC assay method for estimation of indomethacin and its degradation products formed under various stress conditions was developed and validated for routine analysis of indomethacin in its marketed dosage forms.

Methodology : The method uses a volatile buffer and could be extended for LC-MS studies. The separation was carried out on Zorbax Eclipse Plus C18, 3.5 μm (4.6 mm × 100 mm) column with acetonitrile: 10 mM sodium acetate buffer pH 4, 60:40% v/v as the mobile phase at the flow rate of 0.5 ml/min with detection carried out using UV-Visible PDA detector at 226 nm. The retention time of indomethacin was 5 min and linearity was observed in the concentration range of 7.5-75 μg/ml. The developed method was validated as per the ICH guidelines. The drug was subjected to various stress conditions of acid and base hydrolysis, oxidation, photolysis, thermal degradation and neutral condition.

Findings: Considerable degradation was found under all stress conditions and the degradation products were well resolved from indomethacin in the proposed HPLC method. Conclusion: The new method could be used for routine analysis of indomethacin in its dosage forms. The model used for stress degradation studies is simple and could be extended for study of other drug molecules.

Keywords

RP-HPLC, Stability-Indicating, Indomethacin, Validation.

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