In the present research a simple, accurate, precise and cost-effective High-performance thin layer chromatographic method for the estimation of clobazam, in bulk and pharmaceutical dosage form was illustrated. The RF value of the drug was found to be 0.74 in the mobile phase, acetone: toluene: formic acid (1: 1: 0.05 v/v/v). A linear response was observed in the range of 100-700 ng with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of clobazam to analyze the quality of formulation without interference of the excipients.
Two simple, rapid, sensitive and accurate spectrophotometric methods are described for the determination of Pregabalin (PRG) in bulk and pharmaceutical formulations. The methods are based on the reactions of the drug with bromocresol purple (BCP) and bromocresol green (BCG) in buffered hydrochloric acid solutions at pH 1.2 to give coloured ion-pair complexes extractable with chloroform. The coloured products are quantitated spectrophotometrically at 431 nm with BCP and 444.80 nm with BCG. Beer's law is obeyed in the concentration range 10-50 µg/ml with both reagents. Recovery studies gave satisfactory results indicating that none of common additives and excipients interfere the assay method. The proposed methods are found to be simple, accurate and reproducible that was successfully applied for the analysis of capsule formulations. The developed methods are easy to use, accurate and highly cost-effective for routine studies relative to HPLC and other techniques.
A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Pregabalin in bulk and 5-different pharmaceutical formulations, the separation was accomplished on a C18, 5μm Reverse Phase column (250 mm × 4.6 mm) using a methanol : water (95:5, v/v) mobile phase. The compound was eluted isocratically at a flow rate of 0.8 ml /min. The UV detector was set at 288 nm for the detection of Pregabalin (PRG). The method was linear over the range of 5-45 μg/ml and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization. Robustness testing was also conducted to evaluate the effect of minor changes to the chromatographic system and to establish appropriate system suitability parameters. This method was used successfully for the quality assessment of 5-different pharmaceutical formulations with good precision and accuracy.
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