A simple, accurate, and sensitive high-performance liquid chromatography-ultraviolet detection method was developed for simultaneous determination of rosuvastatin with co-administered nonsteroidal anti-inflammatory drugs (meloxicam, ibuprofen, and mefenamic acid) in active pharmaceutical ingredient (API), pharmaceutical formulations, and human serum. Isocratic separation was employed on prepacked Purospher Star C 18 (5 µm, 25 × 0.46 cm) columns at ambient temperature. The mobile phase consisted of methanol:water:acetonitrile (80:17.5:2.5 v/v), pH adjusted to 3.0 with o-phosphoric acid at 1 mL min-1. The drugs in the eluant were monitored at isosbestic point of drugs at 230 nm. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte's chromophore which enhanced sensitivity with linear range. Results: Linear behavior was observed between 0.1 and 2.5 µgmL-1 for rosuvastatin, 0.4 and 10 µgmL-1 for meloxicam, 0.25 and 6.25 µgmL-1 for ibuprofen, and 0.15 and 3.75 µgmL-1 for mefenamic acid, with r 2. 0.998. The relative standard deviation for inter-day precision was ,2 in API, formulations, and human serum. Percent recovery for all drugs was 97.3%-100.89% in API and formulations and 99.3%-100.4% in human serum. Wavelength-programmed analysis made the method more sensitive, where 4 , limit of quantification (LOQ) , 11 and 1 , limit of detection (LOD) , 4 ngmL-1 for API; 6 , LOQ , 10 and 2 , LOD , 3 ngmL-1 for pharmaceutical formulations; and 3 , LOQ , 10 and 1 , LOD , 3 ngmL-1 in human serum, reduced from 9 , LOQs , 23 and 3 , LODs , 7 ngmL-1 for all drug analytes in API; and 4 , LOQs , 17 and 1 , LODs , 6 ngmL-1 in human serum recorded at isosbestic point for rosuvastatin, meloxicam, ibuprofen, and mefenamic acid, respectively. Recovery of drugs was 99.998%-104.000% in all API, formulations, and serum samples. Conclusion: The proposed method can be used for the quantitative analysis of these drugs in raw materials, in bulk drugs, dosage formulations and in human serum and for clinical studies even when the drug is present in low amounts.
An efficient, selective and cost-effective liquid chromatographic assay was developed and validated for the simultaneous quantification of ciprofloxacin and rosuvastatin in Active Pharmaceutical Ingredients (API), pharmaceutical formulations and in human serum. The chromatographic system consisted of mobile phase methanol-water, 90:10 v/v at pH 3.0 adjusted with o-phosphoric acid, pumped at 1.0 mL/min through a prepacked Purospher Star C18 (5 µm, 25 × 0.46 cm) column and effluent was monitored at the isosbestic point (255 nm) as well as at the λmax of individual drugs (243 and 271 nm). The method was validated over a linear concentration range of 0.25-15 µg/mL for ciprofloxacin and 0.33-20 µg/mL for rosuvastatin (r(2) ≥ 0.999). The ranges of reliable response (limits of detection and quantitation) for ciprofloxacin were 3-15 and 9-45 ng/mL and 17-29 and 52-88 ng/mL, respectively, for rosuvastatin in all API, pharmaceutical formulations and human serum. Analytical recovery from human serum was >98% and relative standard deviation (RSD) was <2. The accuracies were 97.13-102.55 and 97.41-101.31% and precisions in RSD were 0.04-1.90 and 0.02-1.23% for ciprofloxacin and rosuvastatin, respectively. No matrix interferences, ion suppression/enhancement and carry-over were detected. The total assay run time was less than 5 min. In another study, for optimum performance the detector was programmed for multiwavelength scanning at the absorption maxima of each component. Consequently, the linearity range was improved and limit of detection and quantitation values were down to 1-4 and 4-12 ng/mL for ciprofloxacin and 3-5 and 9-15 ng/mL for rosuvastatin, respectively. The validation parameters fitted ICH guidelines through the isosbestic and individual λmax approach. The small sample volume and simplicity of preparation make this method suitable for use in human serum samples, pharmaceutical formulations, quality control, drug-drug interaction studies, clinical laboratories, drug research centers and forensic medical centers.
Context: Rosuvastatin is a cholesterol lowering drug. It belongs to class statin. It is prescribed to the patients of coronary artery disease; atherosclerosis; thrombosis; increased low-density-lipoprotein; lipid and triglyceride. Aims:It is a newer drug in market and studies over the pharmacodynamics and pharmacokinetics are in progress. Statin therapy is a long term treatment for which its behavior in the presence of other agents is necessary. For this purpose present study is based on the interaction of the drug with essential and trace elements present in human body or co-administered during multivitamin therapy. Settings and Design: Complexes of rosuvastatin with Cd(II), Cr(II), Mn(II), Fe(III), Co(II), Ni(II) and Zn(II) i.e., metals commonly present in multivitamins, were synthesized in laboratory. Methanolic solution of rosuvastatin with metal chloride salts was reacted. Methods and Material: Reaction between drug and metals was carried out in thermostat at 80 o C for five hours with timely TLC monitoring for completion of reaction. These newly synthesized complexes were identified by IR and NMR spectroscopy and CHN elemental microanalysis and the structure of complexes was proposed. Results: Analyses suggest two molecules of rosuvastatin co-ordinate with the central metal atom through their carboxylic group. CS Chem3D ultra suggests square planner structure of the complex. Conclusions: Synthesis of compounds proposes that rosuvastatin can bind to metals as ligand through its pharmocophore site that may lead to reduced activity of drug and metal both. The study is precursor to in vitro and in vivo study of interaction of drug and metals.
Rosuvastatin is an anti-hypercholesterolemic agent with good anti-inflammatory and antinociceptive responses. The objective of present study was to assess the pharmacological effects of interaction of rosuvastatin with coprescribed ACE inhibitors. For this purpose complexes of Rosuvastatin with enalapril, captopril and lisinopril were synthesized and characterized. Their spectroscopic analyses suggest that hydrogen bonded complexation occurs between rosuvastatin and selected ACE inhibitors at their carboxylic (COOH) and hydroxyl OH sites.The anti-nociceptive effect of complexes was assessed by formalin induced nociception in mice, antiinflammatory effect was evaluated by carrageenan induced paw edema in rats. Neuropharmacological behaviors were also studied on mice.All the complexes of Rosuvastatin showed analgesic behavior in rats and mice. Anti-inflammatory activity of complexes is found insignificant. Enalapril complex keeps sedative activity while complexes with captopril and lisinopril contain anti-depressant behaviors.Results suggest that the interaction of rosuvastatin with ACE inhibitors have consumed the active reacting sites of Rosuvastatin for which its anti-inflammatory, analgesic and gross locomotor behaviors have been affected. So it is suggested that Rosuvastatin should not be co-administered with any of these ACE inhibitors.
The event in the early & late proliferative period of the menstrual cycle can be experienced as physical, psychological, physiological & emotional indicators, sometimes it is well observed as premenstrual syndrome (PMS) among reproductive aged women, specifically characterized by emotional & physical symptoms that consistently occur during the leutal phase of the menstrual cycle. The purpose of our study was to determine the frequency and severity of occurrence of these characterizing symptoms as well as to compare these with PMS in young girls. We also investigated about the impact of these conditions on the quality of life. Women aged 17-35 years with pre-menstrual pain were recruited in the study. PMS related data was collected on record of severity of pain while emotional stress score were calculated by using Sadaf Stress Scale (SSS). According to our results 48% of these women reported sharp pain with 39% having pain in abdomen back and thigh region. According to SSS 26% lies in moderate emotional stress, 30% in mild and 11% in severe emotional stress. Those women having severe intensity of pain reported 80% moodiness, 60% irritability and 40% abnormal laughter. The present results showed consistent and strong relationship between PMS symptoms and level of interference in all domain of women's quality of life. We can conclude that PMS is the most common problem in women that distresses their educational performance and emotional well-being. There should be modified strategies for the detection and management of PMS on women for better quality of life.
Premenstrual syndrome (PMS) is a set of physical, emotional & behavioral symptoms that start during the week preceding menstruation & are alleviated when the menstrual flow begins. The purpose of this study was to evaluate symptoms of PMS in relation to intensity of pain & physical stress by using Sadaf Stress Scale (SSS). PMS affects menstruating women globally & causes extensive personal & public health problems with high degree of absenteeism. It is the most common gynecological problem that has been reported to affect the ability of women to carry out daily activities. Data was collected from women aged 17-35 years having premenstrual pain. The prevalence was determined by questionnaire include issues about exercise, intensity of pain, severity and flow of blood during reproductive cycle. Results shows 15% mild, 14% moderate & 5% sever symptoms of physical stress with only 4% females are interested in doing exercise. Premenstrual pain was one of the most common complain among these females of reproductive age with sever to moderate discomforts during menstruation along with the concerns of heavy or moderate bleeding. It is recommended that inquiries about pelvic pain & menstrual discomforts should be made compulsory in health care centers, so that this major problem could be overcome causing hindrances in routine life with women.
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