Objective: The objective is to study liquid chromatography tandem-mass spectrometry (LC/MS/MS) method for simultaneous quantification of paracetamol (PCM), guaifenesin (GUA), phenylephrine hydrochloride (PE), chlorpheniramine maleate (CPM), and ambroxol hydrochloride (AMB) in tablet dosage form developed and validated as per the International Conference on Harmonization Q2 (R1) guideline. Methods: The chromatograms were developed using a gradient mobile phase of WATER:methanol. Flow rate used was to 0.3 ml/min. Quantitation was performed using multiple reaction monitoring (MRM) mode to study parent to product ion transition, for paracetamol. (m/z 152.0 ≥ 110.0), guaifenesin (m/z 199.0 ≥163.0), phenylephrine hydrochloride (m/z 168.0≥ 150.0), chlorpheniramine maleate (m/z 275.0 ≥ 230.0) and ambroxol hydrochloride (m/z 379.0 ≥ 263.8). Results: The retention times were found to be 1.76, 1.81, 1.90, 2.10, and 2.33 min for PCM, GUA, PE, CPM, and AMB, respectively. The linearity of the method was found to be in the concentration range of 10–200 ng/ml for PCM, GUA, PE, CPM, and AMB. Percentage relative standard deviation values for repeatability and intermediate precision studies were below 2%. Conclusion: Developed method was found to be robust, precise, accurate, rapid and can be used to analyze fixed-dose tablet formulation used in the study.
Ivabradine is a specific heart rate lowering agent, acting by reducing the rate of pacemaker activity in the sinoatrial node. Ivabradine is a novel heart rate lowering medicine for the symptomatic management of stable angina pectoralis and symptomatic chronic heart failure. In multicenter clinical trials, it has been proved that Ivabradine is superior to beta-blocking agents during complex therapy of chronic heart failure accompanied with its beneficial effects related to cardiac remodeling, improvement of the currency of heart failure and diminution of patients rehospitalisation. It is suggested that Ivabradine as a newer agent is a valuable perspective drug for the treatment of congestive heart failure. This review is useful for the future study for researcher involved in formulation development and quality control of Ivabradine. This review article represents the various analytical methods which have been reported for estimation of Ivabradine in pharmaceutical dosage form. The spectrophotometric techniques and Q-absorbance ratio method were reported by the various authors. Many researchers also worked in chromatographic areas like Thin layer chromatography, High performance liquid chromatography, and High performance thin layer chromatography. Ivabradine is also studied by various hyphenated techniques .We reviewed and reported almost all analytical methods with more emphasis on chromatographic mrthodsfor Ivabradine.
Objective: A simple, novel, sensitive, and rapid high-performance thin-layer chromatographic (HPTLC) method has been developed and validated for quantitative determination of fenofibrate in bulk and formulations.Methods: The chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using a single solvent dichloromethane as a simple mobile phase. Densitometric detection was carried out at 292 nm.Results: Rf value of drug was found to be 0.33±0.02. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 20–400° ng band−1° with a regression coefficient of 0.999. The method has proved high sensitivity and specificity.Conclusion: Proposed densitometric method was found to be new, simple, and economic for routine quantification of fenofibrate in bulk and pharmaceutical formulation.
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