Title: Analytical Method Development and Validation of Assay and Dissolution for Nisoldipine ER Tablets by RP-HPLC.
Abstract: The present study has been undertaken in order to develop a new, simple, reproducible validatable, transferable, robust, reliable, accurate and precise individual methodology for the Assay and Dissolution of Nisoldipine in pharmaceutical dosage forms by using HPLC(Reverse phase). An attempt was made in a stepwise manner to develop a simple, rapid, selective and sophisticated Assay method, by High performance liquid chromatography (Reverse phase) for the Nisoldipine. The following stepwise protocol was followed. As a start up, literature survey was done and from the literature survey chemical profile like solubility, chemical structure, pKa value and analytical profile were obtained. From the data obtained, UV spectroscopic study was tried in the first place. Later several trials were done in RP-HPLC using a different combination of mobile phases and finally optimized. After optimization of the HPLC method, validation of the analytical method for the developed RP-HPLC method was done in accordance with the ICH guidelines. An isocratic RP- HPLC method for analysis of Nisoldipine in pharmaceutical dosage form has been developed and validated. Best separation was achieved on a PEERLESS BASIC C18 (100 × 4.6 mm) 1.8μm column using a mobile phase composition of pH 6.8 buffer: Methanol: ACN (30:30:40) at a flow rate of 1.0 mL/min. UV detection was performed at 333 nm. The method was validated for specificity, linearity, precision, accuracy, robustness, ruggedness & solution stability according ICH guidelines. The calibration plot was linear over the concentration range 12.5-75ppm with correlation coefficient 0.9998. The accuracy was good. The HPLC method developed is accurate, precise, reproducible, specific, and stability indicating. The method is
linear over a wide range, economical and utilizes a mobile phase which can be easily repared.
All these factors make this method suitable for quantification of Nisoldipine in bulk drugs and in pharmaceutical dosage forms without interference. It can therefore be concluded that use of the method can save much time and money and it can be used even in small laboratories with very high accuracy and precision. An isocratic RP- HPLC method for analysis of Nisoldipine in pharmaceutical dosage form has been developed and validated. Best separation was achieved on a PRONTOSIL C18 H (100 × 4.6 mm) 3μm column using a mobile phase of composition of pH 3buffer: ACN: Methanol (30:40:30) at a flow rate of 1.5mL/min. UV detection was performed at 333 nm. The method was validated for specificity, linearity, precision, accuracy, robustness, ruggedness & solution stability according ICH guidelines. The calibration plot was linear over the concentration range 10-60ppm with correlation coefficient 0.9997. The accuracy was good. . The data validation shows that the RP-HPLC method is accurate, robust and possesses excellent linearity and precision characteristics. This method can be successfully used for the quantitation of Nisoldipine as active substance, in dissolution studies and in tablet dosage forms. So it can be concluded that the developed method can be easily applied for the routine quality control
analysis of Nisoldipine drug and it’s Formulation.
Publication Year: 2012
Publication Date: 2012-05-01
Language: en
Type: dissertation
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