Adverse drug reaction profi les of commonly used platinum compounds in cancer chemotherapy.

Background: The aim of the present study was to monitor and analyze the pattern of occurrence of adverse drug reactions (ADRs) to commonly used platinum compounds in MNJ Cancer Hospital, Hyderabad. Methods: Cancer patients, who received platinum compounds as chemotherapy regimen, were monitored for adverse reactions. Cancer patients belonging to either gender and of all ages, who were receiving platinum compounds under any standard regimen, were included for the study. Cases that were unlikely, conditional or unaccessible under World Health Organization (WHO)-Uppsala Monitoring Centre causality criteria were excluded from the study. The ADRs were recorded in Central Drugs Standard Control Organization forms. Causality was assessed by the WHO Causality Assessment Scale and Naranjo’s Algorithm. Preventability and severity of ADRs were assessed by modifi ed Schumock and Thornton scale, modifi ed Hartwig and Siegel scale, respectively. Results: Among 100 patients, 78 developed ADRs to platinum compounds. The reactions observed were vomiting, diarrhea, abnormal renal function tests, myelosuppression, anemia, thrombocytopenia, alopecia, and constipation. The WHO Causality Assessment Scale indicated 64.6% “possible” and 35.4% “probably,” but no “certain” reactions. Naranjo’s Algorithm showed 59.4% “possible” 40.6% “probable” reactions. 48% reactions were “defi nitely preventable” 16% were “probably preventable” and 36% were “not preventable.” Modifi ed Hartwig and Siegel Scale of severity assessment showed that 12% reactions were “mild” 69% were “moderate” and 19% were severe. Conclusion: Platinum compounds have high potential for adverse effects. There is a need to improve the management of adverse effects. This study also emphasizes the need to improve pharmacovigilance awareness among physicians in order to improve the pharmacovigilance in India.

Derivative Spectrophotometric Methods for the Determination of Zolpidem Tartrate in Tablets.

Two simple, precise and accurate first derivative spectrophotometric methods were developed for the determination of Zolpidem Tartrate in pharmaceutical formulations in phosphate buffer pH 6.8 and acetate buffer pH 4.0. Beer’s law was obeyed over the concentration range 0.5-20 μg/ml in both phosphate buffer (pH 6.8) (Method A) and acetate buffer (pH 4.0) (Method B). The regression equations were found to be y = 0.101x+0.012 (r2 = 0.999) and y = 0.064x+0.009 (r2 = 0.999) in Method A and B respectively. The % RSD in precision studies was found to be 0.28-0.69 (Intra-day) and 0.31-0.73 (Inter-day) for Method A and 0.25-0.82 (Intra-day) and 0.26-0.57 (Inter-day) for Method B respectively. The % RSD in accuracy studies was also found to be 0.14-0.19 (Method A) and 0.18-0.23 (Method B) with percentage recovery 98.67-99.78 and 98.56-99.83 Method A and B respectively.