Abstract
A rapid and reproducible stability indicating TLC method was developed for the determination of prednisolone acetate and chloramphenicol in presence of their degraded products. Uniform degradation conditions were maintained by refluxing sixteen reaction mixtures for two hours at 80°C using parallel synthesizer including acidic, alkaline and neutral hydrolysis, oxidation and wet heating degradation. Oxidation at room temperature, photochemical and dry heating degradation studies were also carried out. Separation was done on TLC glass plates, pre-coated with silica gel 60F-254 using chloroform: methanol (14:1 v/v). Spots at Rf 0.21 ± 0.02 and Rf 0.41 ± 0.03 were recognized as chloramphenicol and prednisolone acetate, respectively. Quantitative analysis was done through densitometric measurements at multiwavelength (243 nm, λmax of prednisolone acetate and 278 nm, λmax of chloramphenicol), simultaneously. The developed method was optimized and validated as per ICH guidelines. Method was found linear over the concentration range of 200-6000 ng/spot with the correlation coefficient (r2 ± S.D.) of 0.9976 ± 3.5 and 0.9920 ± 2.5 for prednisolone acetate and chloramphenicol, respectively. The developed TLC method can be applied for routine analysis of prednisolone acetate and chloramphenicol in presence of their degraded products in their individual and combined pharmaceutical formulations.
Highlights
Prednisolone acetate (1), is a corticosteroid, used in polychemotherapy of cancer and as an immunosuppressive to treat allergic disorders and hypersensitivity reactions [1,2]
Few HPTLC methods have been reported for the determination of chloramphenicol in combination with benzocaine and 2amino-1-(4-nitrophenyl) propane-1,3-diol (ANPD), and for different corticosteroids including hydrocortisone, hydrocortisone acetate, prednisolone, betamethasone-17valerate, prednisolone sodium phosphate, dexamethasone sodium phosphate and betamethasone sodium phosphate [13]
Suitable separation with best resolution was achieved with chloroform: methanol (14: 1 v/v) which showed sharp bands with Rf value of chloramphenicol at 0.21 ± 0.02 and of prednisolone acetate at 0.41 ± 0.03 (Figure 2)
Summary
Prednisolone acetate (1), is a corticosteroid, used in polychemotherapy of cancer and as an immunosuppressive to treat allergic disorders and hypersensitivity reactions [1,2]. A number of corticosteroid and antibiotic combinations are frequently used as antibacterial agents to cure infections associated with the eye. Simultaneous determination of prednisolone, chloramphenicol and a degraded product, 2- amino-1-(4-nitrophenyl)propane-1,3-diol in ophthalmic solutions through HPLC is reported [12]. Few HPTLC methods have been reported for the determination of chloramphenicol in combination with benzocaine and 2amino-1-(4-nitrophenyl) propane-1,3-diol (ANPD), and for different corticosteroids including hydrocortisone, hydrocortisone acetate, prednisolone, betamethasone-17valerate, prednisolone sodium phosphate, dexamethasone sodium phosphate and betamethasone sodium phosphate [13]. No report for the simultaneous determination of prednisolone acetate and chloramphenicol in the presence of their degraded products through TLCdensitometry has been found so far
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