Confirmatory evidence other than 1hnmr spectroscopic technique for complex formation of diclofenac sodium with go-ghrita

Abstract

Present investigation showing confirmatory evidence for complex formation of Diclofenac sodium (Dic) with Go-Ghrita (GG) by various sophisticated techniques like FT-IR, In-vitro release study, DSC, X-ray diffraction and SEM other than 1 NMR (which is reported earlier). Diclofenac sodium binary mixture in (1:0.5), (1:1), (1:2), (1:3) w/w proportions were prepared by adding to molten Go-Ghrita kept over a water bath at 65-70 o C with continuous stirring. Organoleptic and Physico-chemical properties of GG (procured from Magan Sangrahalaya, Wardha) were as per the specifications given in Ayurvedic Pharmacopoeia (AP) and Indian Pharmacopoeia (IP). All proportions were subjected for FT-IR and in-vitro release behaviour (SGF, P H 1.2 for 2 Hrs and SIF, P H 6.8 for 7 Hrs) and on basis of it, optimized (1:1) w/w proportions were further analyzed and characterized for Differential Scanning Calorimetry, X-ray diffraction and Scanning Electron Microscopy. Carbonyl stretching of benzene acetic acid group to slight higher frequency 9.23 % cm -1 (increase) and (–C=O) linked (-OH) band stretching to slight lower frequency 0.57 cm -1 (decrease) shown in FT-IR spectra, supported by in-vitro release of Diclofenac sodium 99.13±0.31% of (1:1) w/w in sustenance form than remaining. Retention of peaks with lesser intensity in binary mixture of drug with GG, revealed crystalline as well as non-crystalline (amorphous) nature in X-RD, Slight lowering of 17.6 0 C Tm and enthalpy change of 8.51 % (loss) in DSC, and entrapment of Diclofenac sodium crystals in Dic-GG binary mixture shown in SEM photographs, reflecting possible evidence for the formation of inclusion type complex between Diclofenac sodium and GG.