The Pharmaceutical and Chemical Journal

1-7

Authors: Kedar Gautam, Binod Lekhak, Prem P Triphatee, Dwij R Bhatta

Carbapenem-resistant Enterobacteriaceae has challenged the therapeutic efficacy and raised the most worrisome global issue of public health importance. The study was conducted to determine the burden of carbapenem resistant isolates of Enterobacteriaceae producing different types of β-lactamases. During the study period, a total of 310 enterobacterial pathogens were isolated and identified from the clinical specimens obtained from the patients visiting Kanti Children Hospital. By Kirby Bauer disc diffusion method, β-lactamase producers and multidrug resistant isolates were detected and ESBLs and carbapenemase producers were screened among them. Phenotypic detection of ESBLs was done by Combination disc test. Modified Hodge test was employed for detection of carbapenemase producers and they were typified by inhibitor based combination disk tests. A total of 251 (81.0%) isolates were β-lactamase producers and 213 (68.7%) were multidrug resistance among the Enterobacteriaceae. Typification of β-lactamases from 23 (7.4%) Modified Hodge Test positive isolates assorts 4 as KPC producers, 11 as MBL producers, 3 as AmpC β-lactamase producers and 1 with both KPC and MBL enzyme while 4 remained unclassified. The majority of carbapenem resistants were E. coli (52.1%) followed by K. pneumoniae (34.8%) and most of the CRE were resistant (56.52%) to all the combinations of ESBL test. Various classes of carbapenemases were found to have emerged among Enterobacteriaceae in Nepal. Since, the profound variation is found in β-lactamases of CRE, to reduce the risk of severe calamity effective detection procedures are mandatory in all clinical laboratories.

17-21

Authors: Mayank Bapna, Jadav Payal Balubhai

A simple, accurate and precise RP-HPLC method was developed for simultaneous estimation of Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin. EclipseC18 (250mm×4.6mm) 5µ (particle size) was used as stationary phase. The mobile phase used was KH2PO4 buffer of pH 6.3: Acetonitrile 30:70 V/V. The mobile phase was delivered at flow rate 1.5 ml/min. UV detection was set at 254nm. The retention time of Betamethasone dipropionate, tolnaftate and Iodochlorhydroxyquin was found to be 5.2 minutes, 9.8 and 7.2 minutes respectively. Linearity was observed over the concentration range of 3.9-9.1µg/ml, 60-140 µg/ml and 60-140 µg/ml for Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin respectively. The LOD was found to be 0.44 µg/ml, 6.49 µg/ml and 4.64µg/ml for Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin respectively. Whereas LOQ was found to be 1.34 µg/ml,19.67 µg/ml and 14.08 µg/ml for Betamethasone dipropionate ,Tolnaftate and Iodochlorhydroxyquin respectively Moreover, the % RSD for repeatability, inter and intraday precision was found to be less than 2%, which reveals that the method is precise. The % recovery was found to be 100.84% for betamethasone dipropionate, 101.11% for tolnaftate and for 100.53% Iodochlorhydroxyquin. However, the change in flow rate and mobile phase ratio also did not show any significant variance. Assay of the combined dosage form finalized the applicability of this method for simultaneous estimation of Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin in combined dosage form.

30-40

Authors: Vikram Kumar, Rabijit Bharadwaj, Gaurav Gupta, Shailesh Kumar

Many different strategies of high performance liquid chromatographic method development are being used today. This overview describes a strategy for the systematic development of High performance liquid chromatographic (HPLC) methods. It is an analytical tool which is able to separate, detect and quantify the drug, its various impurities and drug related degradants that can form on synthesis or storage. HPLC involves the understanding of chemistry of drug substance and facilitates the development of the analytical method. Many chromatographic parameters were evaluated in order to optimize the method. Appropriate mobile phase, stationary phase, column, column size, temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as impurities and degradants. In this paper we have discussed the different physical and chemical parameters that govern the HPLC process and operation and suggested method development for the most optimum conditions based on the analytes.

52-59

Authors: Ashutosh Pareek, Vivek Jain, Yashumati Ratan, Mahendra Singh Ashawat

The present study was conducted to develop a new simple, rapid, precise, sensitive, eco-friendly UV-spectroscopic method for the quantitative determination of Pefloxacin Mesylate in bulk form and prepared in-situ gelling ocular formulations. Method was successfully developed in simulated tear fluid pH 7.4 and further validated in accordance with International Conference on Harmonization (ICH) Q2B guidelines. In line to this, it was tested for linearity, accuracy, precision, detection limit, quantification limit, stability testing, Sandell’s sensitivity and molar absorptivity. Finally developed method was applied to conduct assay of Pefloxacin Mesylate and recovery study in developed in-situ gelling ocular formulations. The absorption maximum of the drug was found to be 272 nm and linearity was observed from 0.5-20 µg/ml with a regression coefficient of 0.999. Validation and statistical results strongly suggested that the developed UV spectroscopic method was accurate, precise, sensitive, versatile and stable. It could be a feasible eco-friendly alternate for the rapid analysis of Pefloxacin Mesylate in bulk as well as in-situ gelling ocular formulations.