ABSTRACT
The aim of the study is to compare efficacy of intravenous (i/v) Palonosetron (75mcg), i/v Ondansetron (4mg) and i/v Dexamethasone (5mg) as prophylactic agents for reducing post-operative nausea and vomiting that follows laparoscopic cholecystectomy. Methods: This prospective randomized double blind study was conducted in the Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur. The study participants comprised of patients undergoing elective laparoscopic cholecystectomy surgeries under general anaesthesia. A total of 90 patients i.e. 30 in each of the three groups were enrolled for the study. Enrolled patients were randomly allocated to received with i/v Dexamethasone (5 mg) or i/v Ondansetron (4mg) or i/v Palonosetron (0.075 mg). The patients in the three groups were monitored and symptoms charted on basis of Post Operative Nausea and Vomiting (PONV) scale. Results: Palonosetron 0.075mg single intravenous dose given prior to induction of anaesthesia achieves 100% complete response with 3.33% reported side effect, and none needed rescue antiemetic. Dexamethasone 5mg single intravenous dose given prior to induction of anaesthesia achieves 93.33 % complete response with none reporting side effect and 6.67% needing rescue antiemetic. Ondansetron 4mg single intravenous dose given prior to reversal of neuromuscular blockade achieves 66.67 % complete response with 20% reporting side effect and 33.33 % needing rescue antiemetic. Conclusion: I.V. Palonosetron and Dexamethasone are equally potent and superior antiemetics than Ondansetron in the prevention of PONV in patients undergoing elective laproscopic cholecystectomy under general anaesthesia.
ABSTRACT
A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 µgmL-1), LOQ (0.13-0.14 µgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found.
Desenvolveu-se método indicador de estabilidade por Cromatografia a Líquido de Alta Eficiência (CLAE) com pequeno tempo de corrida e validado para o ensaio de impurezas relacionadas ao processo de produção de pantoprazol em batelada. A determinação do fármaco, de suas impurezas potenciais e dos produtos de degradação foi realizada com coluna de ODS Hypersil, utilizando gradiente com tampão de fosfato 0,01 M pH 7 e acetonitrila como eluente, no comprimento de onda de detecção de 290 nm. A velocidade de fluxo foi fixada em 1 mLmin-1. O procedimento se mostrou específico, linear (r=0,999), com recuperação (97,9-103%), LOD (0,043-0,047 µgmL-1), LOQ (0,13-0,14 µg mL-1) e robusto. Robustez aceitável indica que o método de ensaio não é afetado por variações pequenas, exceto as planejadas. O pantoprazole degradou em condições ácidas, oxidativas e sob condições de estresse fotolítico. O fármaco foi estável em condições alcalinas e de calor seco. Este método tem sido sucessivamente aplicado à formulação farmacêutica e não se encontrou interferência de excipientes.