Stress degradation studies and development of stability-indicating TLC-densitometry method for determination of prednisolone acetate and chloramphenicol in their individual and combined pharmaceutical formulations

Prednisolone acetate (1), is a corticosteroid, used in polychemotherapy of cancer and also as an immunosuppressive to treat allergic disorders and hypersensitivity reactions [1,2]. Chloramphenicol (2), an antibiotic, possesses broad spectrum antibacterial activity and is used for the treatment of rickettsial and chlamydial diseases, gram + ve and gram -ve bacterial infections and topically for superficial conjunctivial infections [3]. A number of corticosteroid and antibiotic combinations are frequently used as antibacterial agents to cure infections particularly associated with the eye. These combinations are available in different formulations including eye ointment, eye drops and ophthalmic suspensions. Ophthalmic preparations of prednisolone acetate along with chloramphenicol are widely practiced for the treatment of superficial eye infections. However, this combination is not official with British Pharmacopoeia or US Pharmacopoeia. Many analytical methods have been reported for the determination of prednisolone acetate in cosmetics, Chinese medicinal preparations, human serum, urine and pharmaceutical preparations [4-6]. HPLC and UPLC methods are also reported for the estimation of chloramphenicol in aquatic products, pharmaceutical preparations, cosmetics comedo cream, blood, gastric contents, urine, tissues and cerebrospinal fluid [7-11].Simultaneous determination of prednisolone, chloramphenicol and a degraded product, 2- amino-1-(4-nitrophenyl)propane-1,3-diol in ophthalmic solutions through HPLC is also reported [12]. Few HPTLC methods have also been reported for the determination of chloramphenicol in combination with benzocaine and 2-amino-1-(4-nitrophenyl) propane-1,3-diol (ANPD), and for different corticosteroids including hydrocortisone, hydrocortisone acetate, prednisolone, betamethasone-17-valerate, prednisolone sodium phosphate, dexamethasone sodium phosphate and betamethasone sodium phosphate [13]. No report for the simultaneous determination of p