AN ENVIRONMENTALLY BENIGN APPROACH FOR RAPID ANALYSIS OF INDOMETHACIN USING A STABILITY-INDICATING RP-HPLC METHOD

Abstract

A green RP-HPLC method for analysis of indomethacin (IND) in bulk drug, nanoemulsions, and various marketed formulations was developed and validated in the present investigation. The chromatographic identification was achieved on a Lichrosphere 250 × 4.0 mm RP C₈ column having a 5-µm packing as a stationary phase using a green solvent ethyl acetate (100% v/v) as a mobile phase, at a flow rate of 1.0 mL/min with UV detection at 318 nm. The proposed method was validated for linearity, selectivity, accuracy, precision, robustness, sensitivity, and specificity. The utility of the method was verified by assay of IND in developed nanoemulsion, marketed tablet, capsule, suppository, and injection. The proposed method was found to be selective, precise, accurate, robust, sensitive, and specific. The amount of IND in developed nanoemulsion and all marketed formulations ranged from 98.34–101.40%. The proposed method successfully resolved IND peak in the presence of its degradation products which indicates the stability-indicating property of the proposed method. These results indicate that the proposed method can be successfully employed for routine analysis of IND in bulk drug and pharmaceutical dosage forms.

Keywords:

• ICH Guidelines
• indomethacin
• nanoemulsion
• RP-HPLC
• UV detection
• validation

ACKNOWLEDGMENT

The authors are grateful to the Center of Excellence in Biotechnology Research (CEBR) and College of Pharmacy, King Saud University, Riyadh, Saudi Arabia for providing the facilities to carry out these studies. The authors are also thankful to Gattefosse (France) for providing the gift samples of Labrafil and Transcutol-HP.

Notes

*95% confidence interval.

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