DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HCl AND NIMESULIDE FROM TABLET DOSAGE FORM

Abstract

A new simple, specific, precise and accurate reversed-phase liquid chromatography method has been developed for simultaneous estimation of Drotaverine HCl (DRO) and Nimesulide (NIM) in tablet formulation. The separation was achieved on a 5-micron C18 column (250 X 4.6 mm) using mobile phase consisting of a mixture of water: acetonitrile: methanol 30: 35: 35 % (pH 2.5, adjusted with orthophosphoric acid). The flow rate was maintained at 1.0 ml/min, with an average operating pressure of 2630 psi. The detection of the constituents was done using UV detector at 295 nm for DRO and NIM. The retention time of DRO and NIM were approximately 5.6 and 10.6 min respectively. Recovery study values of DRO and NIM is 100.06+0.40 and 100.13+0.34 respectively, relative standard deviation of less than 2% for the assay show that the method is precise, accurate and linear in the concentration given and demonstrate the method developed is rugged and robust. Linear response obtained for DRO was in the concentration range 50-250 µg/ml and NIM in the range 125-625 µg/ml.

Stability-indicating Reversed Phase-Ultra Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Encorafenib and Binimetinib in Formulation

“…The developed method for ECRB and BMTB was subjected to validation for the parameters, like system suitability, robustness, linearity, LOD, precision, LOQ, and accuracy as per the ICH guidelines. [11][12][13][14][15]…”

“…Intermediate precision was evaluated by infusing six standard solutions and six sample solutions on different days by different employees on different chromatographic systems. [14,16] The peak responses of all the chromatograms were taken, and standard deviation, % RSD, and percentage assay of sample solutions were calculated. The findings were shown in Tables 2 and 3.…”

A a Validated Reverse-Phase High-Performance Liquid Chromatography-Charged Aerosol Detector Technique for the Simultaneous Estimation of Sitagliptin and Ertugliflozin in Pure and Pharmaceutical Dosage Forms

“…Optimized RP-HPLC-CAD technique was validated as per the International Council for Harmonization validation parameters [26][27][28][29][30].…”

“…System precision carried out to determine the HPLC system condition. System precision was calculated by infusing six standard solutions, and finally, the percentage relative standard deviation (RSD) was calculated from the peak response [28]. Intermediate precision was evaluated by the examination of three dissimilar concentrations on different days and percentage RSD values were determined by calculating from resultant findings.…”

Development and Validation of Rp HPLC Method for the Simultaneous Estimation of Atenolol and Chlorthalidone in Tablet Formulation

“…Analytical methods reported for quantitative determination of ATN individually in pharmaceutical formulations or biological fluids are HPLC [5,6,7] and UV. [8,9,10] Analytical methods reported for quantitative determination of CTD individually in pharmaceutical formulations or biological fluids are HPLC [11,12,13,14] , UV [15,16] and HPTLC. [17,18] These drugs are used in combination therapy not only because blood pressure control is often inadequate using monotherapy but also because combination therapy can simplify dosing regimens, improve compliance, decrease side effects and reduce cost.…”