ABSTRACT
Inserting chloramphenicol (CL) and hydrocortisone acetate (HCA) in cream preparation is intended to have activityagainst skin infection and dermatitis and such a product is available in the Indonesian market. Due to its capabilityas a separation technique, chromatography is widely used for the analysis of mixture in pharmaceutical products.The objective of this study was to develop high-performance liquid chromatography (HPLC) combined with anexperimental design for an effective analysis of CL and HCA in a cream formulation. In this study, the experimentalBox–Behnken design (BBD) was used. BBD is one of the useful experimental designs for the optimization ofchromatographic separation and analysis and for getting a better understanding of the interaction of studied factors onHPLC separation quality. Separation and HPLC analysis of CL and HCA were performed using a Shimadzu LC-20ADchromatograph, a Waters X-Bridge C-18 column (250 × 4.6 mm ID, 5 µm), and a UV-Vis detector at 261 nm. HPLCmethod was validated according to the International Conference on Harmonization by determining several analyticalperformances intended for the method’s purpose. Based on BBD, the optimal condition of HPLC was obtained usinga mobile phase of acetonitrile 47%– 53%, with a flow rate of 0.9 ml/minutes and a column temperature of 38°C. Thevalidation of HPLC resulted in the selectivity of a method with a resolution value of ≥1.5, linearity with a correlationcoefficient of >0.999, intraday and inter-day precisions with relative standard deviation values of ≤1.9%, and recoveryvalues in the range of 98%−102%. The validated method is successfully used for the analysis of CL and HCA in creamformulations. BBD could be an effective design to get the optimum reversed HPLC condition for the separation of CLand HCA in a cream formulation
ABSTRACT
Background and Objective: Oral Submucous fibrosis (OSMF) is a chronic debilitating disease and a well recognized premalignant condition of oral cavity. The exact pathogenesis is not well established but the cause is believed to be multifactorial. The most commonly used treatment regimen is combination of Hydrocortisone acetate or Triamcinolone Acetonide with hyaluronidase and recently oral Pentoxifylline, but studies of its long term effect are lacking. The present study was therefore conducted to evaluate the long term effectiveness of afore said drugs. Material & methods: In the present study 60 previously treated patients of OSMF were registered. Out of which 34 patients had received Inj. Hydrocortisone acetate (1.5ml) mixed with Hyaluronidase (1500 I.U.) at weekly interval for 22 weeks, 15 patients had received Inj. Triamcinolone Acetonide (10mg/ml) mixed with Hyaluronidase (1500 I.U.) at biweekly interval for 22 weeks and 11 patients were given Tab Pentoxifylline (Trental) 400mg three times daily for a period of 7 months. Long term outcome was evaluated on the basis of symptom score and sign score. Results: There was statistically significant improvement between long term follow up score and immediate Post-treatment symptom score ( p value < 0.05 ) Interpretation and Conclusion: It was concluded that the improvement in symptoms and signs following treatment increased further or maintained in long term follow up
ABSTRACT
Background & objective: Oral submucous fibrosis is a common premalignant condition caused by chewing arecanut and other irritants in various forms. Its medical treatment is not yet fully standardized, although the optimal doses of its medical treatment is in the form of hydrocortisone acetate combined with hyaluronidase. The problem with the prevailing treatment was injections at weekly interval. In this study we compared the efficacy of hydrocortisone acetate and hyaluronidase at weekly interval versus triamcinolone acetonide and hyaluronidase at 15 days interval. Methods: Patients of OSMF (100) were randomly divided into two groups A and B. Group A patients received combination of hydrocortisone acetate (1.5 ml)/hyaluronidase (1500 IU) at weekly interval submucosally in pterygomandibular raphe, half dose on each side for 22 wk. Group B patients received combination of triamcinolone acetonide (10 mg/ml)/ hyaluronidase (1500 IU) at 15 days interval for 22 wk. Treatment outcome was evaluated on the basis of improvement in symptom score, sign score and histopathological improvement. Student’s ‘t’ test was applied for comparing the results. Results: No statistically significant difference in symptom score, sign score and histopathological improvement was seen between the two groups. Interpretation & conclusion: Treatment regimen of group B was more convenient to the patients because less number of visits required and cheap. No side effects were seen. A follow up study is required to see long term effects.