Formulation, optimization, qualitative and quantitative analysis of new dosage form of corticosteroid

Abstract

Abstract Background The objective of the present research work is to develop the entirely new drug product formulation (Ophthalmic Suspension) which belongs to the therapeutic class of steroids drugs (Corticosteroid). There are different dosage forms of Triamcinolone acetonide to treat different systemic as well as topical diseases as per patient symptomatic conditions. Due to non-availability of this active drug (Triamcinolone acetonide) ophthalmic dosage form in the national and international market research work is carried out to enter in this dosage form. Results In the formulation design and development, different inactive like polysorbate 30 mg/mL, PEG-12 glyceryl dimyristate 70 mg/mL, ethyl alcohol 10 µL/mL, citric acid 1 mg/mL, sodium citrate 3.5–4.0 mg/mL, BKC 0.15 mg/mL and water for injection have been used at different stages in different proportions during the manufacturing procedure. Gradient HPLC, C18 column, 5 µm, 100 A, 3.9 mm × 300 mm, detector UV/Vis @ 254 nm, column oven, auto-sampler, degasser, is used and this analytical testing method is validated to obtain the accurate results. The excipients play different roles including solvent, antioxidant, solubilizer, emulsifier, antibacterial, preservative, anticoagulant, antimicrobial agent, surfactant and buffers in the stability of active drug for its excellent therapeutic output results. Correlation coefficient factor is greater than 0.999 which indicates that the method has good linearity at proposed concentration against triamcinolone acetonide. Conclusions Excellent physical and chemical properties like physical appearance, pH, specific gravity, viscosity, re-suspendability, sedimentation volume is accomplished to meet the requirements of the eye treatment products. On the basis of experimental results achieved during validation process, it can be assumed that the current analysis method is more accurate, precise, specific, linear and consistency indicating in the range of 70 to 130% of the analyte concentration. From the physical, chemical behaviors and chemical assay of the newly developed drug formulation of corticosteroid (triamcinolone acetonide) it is concluded that it can be probably put for further clinical trial in different phases for human use.