DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF IBUPROFEN AND FAMOTIDINE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, sensitive, and precise high performance thin layer chromatographic method (HPTLC) has been developed for the estimation of ibuprofen and famotidine in combined dosage form. The method employed HPTLC aluminum plates precoated with silica gel 60F₂₅₄ as the stationary phase while the solvent system was methanol: ethyl acetate: hexane: ammonia (2:6:1:0.5, v/v/v/v). The Rf values were observed to be 0.41 ± 0.02 and 0.69 ± 0.02 for ibuprofen and famotidine, respectively. The densitometric analysis was carried out in absorbance mode at 264 nm. The method was linear in the range of 320–9600 ng/band for ibuprofen and 10–300 ng/band for famotidine. The method was validated with respect to accuracy, precision, specificity, and robustness. The limit of detection for ibuprofen and famotidine were found to be 110 and 3 ng/band, respectively. The limit of quantification for ibuprofen and famotidine were found to be 320 and 10 ng/band, respectively. The method was successfully applied to the estimation of ibuprofen and famotidine in combined dosage form.

Keywords:

• famotidine
• HPTLC
• ICH guideline
• ibuprofen
• pharmaceutical formulation
• validation

ACKNOWLEDGMENT

The authors are thankful to Mercury pharmaceuticals Ltd., Baroda and Blue Cross Laboratory, Mumbai, India, for providing gift samples of IBU and FAM, respectively. The authors are very thankful to Principal, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidyanagar, for providing necessary facilities to carry out research work.

Notes

^a RSD is relative standard deviation and “n” is number of determinations.

^a Mean value ± standard deviation of three determinations; tablet formulation A is DUEXIS (Horizon Pharma, USA) containing labeled amount of 800 mg of ibuprofen and 26.6 mg of famotidine.

Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/ljlc.