Statins are a group of medicines that can help to lower the level of low-density lipoprotein (LDL) cholesterol "bad cholesterol" in the blood. Having a high level of LDL cholesterol is potentially dangerous, as it can lead to a hardening and narrowing of arteries (atherosclerosis) and cardiovascular disease (CVD), atorvastatin is one of the oldest member of the statin family and is used in the treatment of dyslipidemia and the prevention of CVD. Atorvastatin was first made in August 1985 and from 1996 to 2012 under the trade name Lipitor, atorvastatin became the world's best-selling drug. Numerous analytical methodologies are available for the quantification of atorvastatin and its content in pharmaceutical preparations and in biological fluids.
3 November 2021 in Journal of Applied Pharmaceutical Science
The pharmaceutical industries rely heavily on liquid chromatographic methods for routine quality control, which utilize hazardous solvents and have a direct impact on the environment. Hence, the development of green liquid chromatographic methodologies has become vital with its green assessment and its application in quality control laboratories has become the need of the hour. The prime focus of the existing study was to develop analytical quality by design aided stability indicating green high performance liquid chromatography (HPLC) method for the estimation of rosuvastatin calcium (RC) in a tablet dosage form. The critical chromatographic factors were the % of ethanol in the mobile phase, and flow rate, their overall effect on the responses like capacity factor, tailing factor and theoretical plates were studied to optimize the method. A rotatable central composite design was employed, and the optimized conditions for chromatographic separation were made with a run time of 12 minutes using Zorbax C18 column (4.6 × 150 mm, 5 µm) with 0.5% v/v acetic acid and ethanol (52.7:47.3 v/v) as components of a mobile phase, flowing at a rate of 0.978 ml/minute. Photodiode array detection was carried out at 246 nm. According to the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, the proposed method was validated and stress studies revealed that RC is prone to acidic and photolytic stress conditions. An analytical eco-scale score evaluated the greenness profile, and a software-based evaluation Analytical Greenness metrics, which affirmed excellent greenness. The developed HPLC method is more eco-friendly and shall be adopted in the routine quality control of RC in a tablet dosage form.
8 April 2019 in Critical Reviews in Analytical Chemistry
Bacterial resistance to antibiotics is a growing phenomenon in the world. Considering the relevance of antimicrobials for population and the reduction in the registration of new antimicrobials by regulatory agencies, proper quality control is required to minimize the spread of bacterial resistance and ensure the effectiveness of a treatment, as well as safety for the patient. The recent addition to the antimicrobial world is the oxazolidinone classes of antibiotics, especially useful to treat infections caused by Gram-positive bacteria. Eperezolid and linezolid (LIN) are the two members of the oxazolidinone class of antibiotics. LIN was the first oxazolidinone approved by the Food and Drug Administration. The present review focuses on the analytical methods for the assessment of LIN in pharmaceuticals and biological matrices. The critical validation parameters like the linearity, limit of detection, limit of quantification are discussed for the individual method. Also the critical quality attributes like the sensitivity and the sample preparation techniques for bioanalytical methods are also discussed. Furthermore, some future trends that can be incorporated in the determination of similar drugs are also suggested.
1 January 2018 in Research Journal of Pharmacy and Technology
This work introduces three eco-friendly UV spectrophotometric methods for the simultaneous estimation of Paracetamol, Aceclofenac and Eperisone Hydrochloride in pharmaceutical tablet formulation. The procedures employed were simultaneous equation method and multivariate chemometric methods with phosphate buffer pH 7.80 as diluent. The simultaneous equation method encompasses absorbance measurement at three different wavelengths (λmax of the drugs). It exhibits linearity between 12–18 µg mL−1 for paracetamol, 3.69–5.53 µg mL−1 for Aceclofenac, and 2.76–4.15 µg mL−1 Eperisone hydrochloride. The results obtained for accuracy and precision by the simultaneous equation method were within the permissible limits. Principal component regression and partial least squares were the tools used for chemometric methods. The calibration set and prediction set were constructed, and the UV spectra were recorded in zero order mode, further subjected to chemometric analysis. The % recoveries obtained for Paracetamol, Aceclofenac, and Eperisone Hydrochloride by chemometric techniques showed good accuracy, and the results obtained for analytical figures of merit were acceptable. Statistical comparison of the assay results obtained for the proposed methods showed no significant difference found among the methods using one way analysis of variance. Greenness evaluation tools revealed the greenness profile of the proposed methods and found them to be ecofriendly. The described methods were appropriate for routine quality control laboratories, facilitating eco-friendly, fast, and cost effective determination of Paracetamol, Aceclofenac, and Eperisone Hydrochloride in Acemyoset P tablets.