Najmul Hasan

Simultaneous determination of antihistamine anti-allergic drugs, cetirizine, domperidone, chlorphenamine maleate, loratadine, meclizine and buclizine in pharmaceutical formulations, human serum and pharmacokinetics application

This article describes a new, accurate and highly specific high performance liquid chromatographic method with UV detection (HPLC-UV) for the simultaneous determination of cetirizine HCl (CZ), chlorphenamine maleate (CPM), loratadine (LTD), domperidone (DP), buclizine (BZ) and meclizine (MZ) in pharmaceutical dosage form and human serum, involving pyridoxine (PYD) as the internal standard. The mobile phase consists of heptane sulphonic acid salt buffer and acetonitrile, drawn at a flow rate of 1.0 mL min−1 using a symmetry C18 column with UV detection at 230 nm. The intraday and inter-day precision measurements showed coefficients of variation always less than one. The calibration curve was tested in the range of 10–2150 ng mL−1 and the correlation coefficient of >0.9990 in all cases was obtained. The averages of the absolute and relative recoveries were found to be in the range of 98 to 102%. Up to six antihistamines were separated in the same chromatogram with good resolution. The proposed HPLC method has reasonable applications in pharmaceutical tablet dosage form and pharmacokinetics studies.

Simultaneous Determination of NSAID and Antimicrobial Preservatives Using Validated RP-HPLC Method: An Application in Pharmaceutical and Clinical Laboratories

A stability indicating, accurate, specific, precise and simple high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Dexibuprofen along with its preservatives i.e. Sodium Benzoate, Methylparaben, and Propylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Acetate Buffer: Acetic Acid (0.1 M) (50:50:0.3 v/v/v) (pH 5.5) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar® μBondapak® C18 column monitored at wavelength of 230 nm. The calibration curve was linear with a correlation coefficient of more than 0.9995 for the drugs. The averages of the absolute and relative recoveries were found to be 100.07%, 99.82%, 99.91% and 99.97% for Dexibuprofen, Sodium Benzoate, Methylparaben and Propylparaben respectively with 5 to 25 ng mL-1 limit of quantification and 1.5 to 7 ng mL-1 limit of detection. The drugs were subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation). Maximum degradation was observed in base and 35% H2O2 while found almost stable in the other stress conditions. The studies of forced degradation prove the stability indicating power of the method. The developed method was validated in accordance to ICH guidelines. The proposed High-performance liquid chromatographic method was successfully applied to quantify the amount of Dexibuprofen and three most common microbial preservatives in bulk, dosage form and physiological fluid.

Novel HPLC method for quantitative determination of cefazolin sodium in pharmaceutical formulations

This paper reports a validated high-performance liquid chromatography method which is rapid, highly specific, and accurate for determination of cefazolin sodium in injec table pharmaceutical formulations. Separation was carried out using a Hibar ® µBondapak ® C 18 column with a mobile phase consisting of an acetonitrile to monobasic sodium phosphate buffer ratio of 17:83 and a flow rate of 1.0 mL per minute, and monitoring at a wavelength of 254 nm. The calibration curve was linear, with a correlation coefficient .0.9995 in the range of 5-100 µg/mL. Drug recovery was 98.35%-100.86%, with a limit of detection of 12.92 ng/mL and a limit of quantification of 43.09 ng/mL. The drug was subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation), where maximum degradation was observed. Forced degradation studies confirmed stability indicating power of this method, which was validated in accordance with International Conference on Harmonization guidelines and used successfully to quantify the amounts of cefazolin sodium in bulk injectable formulations

Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum

A reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : 0.3 v/v/v), at flow rate 1.0 mL/min using a Hibar μBondapak ODS C18 column monitored at dual wavelength of 266 nm and 205 nm for phloroglucinol and trimethylphloroglucinol, respectively. The drugs were subjected to stress conditions of hydrolysis (oxidation, base, acid, and thermal degradation). Oxidation degraded the molecule drastically while there was not so much significant effect of other stress conditions. The calibration curve was linear with a correlation coefficient of 0.9999 and 0.9992 for PG and TMP, respectively. The drug recoveries fall in the range of 98.56% and 101.24% with 10 pg/mL and 33 pg/mL limit of detection and limit of quantification for both phloroglucinol and trimethylphloroglucinol. The method was validated in accordance with ICH guidelines and was applied successfully to quantify the amount of trimethylphloroglucinol and phloroglucinol in bulk, injectable form and physiological fluid. Forced degradation studies proved the stability indicating abilities of the method.

Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum.

In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar® Lichrosorb® C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL-1 and 0.1 to 0.8 ng mL-1 respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.

Spectrophotometric Quantitation of Mebeverine in Bulk Drug and Pharmaceutical Formulations using Multivariate Calibration Technique

S is characterized by a broad range of unusual behaviors that cause profound disruption in the lives of people suffering from the condition, as well as in the lives of the people around them. Schizophrenia strikes without regard to gender, race, social class or culture. In treating schizophrenia patients, chlorpromazine a conventional anti-psychotic drug, which was discovered in 1950’s, has an exhaustively characterized efficacy/safety profile. However, chlorpromazine is not specific to one site of action within the body. Consequently, it is known to cause adverse effects ranging from dry mouth, blurred vision and urinary retention as well as restlessness, tardive dyskinesia which can be difficult to reverse. Second-generation antipsychotic agents like clozapine, risperidone, olanzapine etc., were found to be inconsistently more effective than first-generation agents in alleviating negative, cognitive, and depressive symptoms and had a lower liability to cause tardive dyskinesia; these modest benefits were principally driven by the ability of second-generation antipsychotics to provide equivalent improvement in positive symptoms along with a lower risk of causing extra pyramidal side-effects. Data from two major government-funded studies of comparative antipsychotic effectiveness in schizophrenia contradict the widely prevalent belief that the newer second-generation medications are vastly superior to the older first-generation drugs. K. Jahnavi Ramya et al., J Pharmacovigilance 2013, 1:4 http://dx.doi.org/10.4172/2329-6887.S1.009S media has become the medium of choice for people to talk about their experiences with medicine, positive or negative. Facebook, Twitter, Drug specific blogs and the like have made it easy for anyone to have a forum. What is real and what is noise? How do you deal with all the background to make any kind of sense from the potential signals that are being sent? Come hear how our unique approach allows us to weed through and interpret the data. Come see what we are hearing. Jaidev Dasgupta et al., J Pharmacovigilance 2013, 1:4 http://dx.doi.org/10.4172/2329-6887.S1.009Gymnema sylvestre (GS) and Metformin both reducing insulin resistance. GS stimulate ß-cell function, increase ß-cell number, increases the enzyme activity responsible for glucose uptake and utilization. Metformin (MF), a biguanide increases glucose uptake and utilization in skeletal muscle and reduces hepatic glucose production. The effect of the combination of GS (100 mg/kg p.o and 500mg/kg p.o.) and MF (50 mg/kg and 100 mg/kg p.o.) on the pharmacokinetic parameters of MF was studied in STZ induced diabetic rats after single dose administration and multiple dosing for 15 days. Pharmacodynamic interactions were as well as studied by determing the effect of combination therapy on the serum glucose levels of STZ induced diabetic rats before and after multiple dosing for 14days. Histopathological studies were carried out by excising the pancreas after the treatment and the effect of combination on the volume of beta cells were compared to that of single (either MF alone or GS alone) administration and control. Pharmacokinetic studies revealed a decrease in the bioavailability of MF when given in combination with GS. The decrease in bioavailability was contributed by decrease in absorption rate constant and increase in clearance where as in the Pharmacodynamic study the combination in general showed decrease in serum glucose levels which was contributed by the hypoglycemic property of GS. But the combination did not decrease the serum glucose levels comparable to MF when given alone. Histopathological studies revealed that combination of GS with MF increased the volume of islets cells of pancreas. These observations show that Gymnema sylvestre is a potent hypoglycaemic but it contributes to a decrease in hypoglycemic effect of Metformin. ISSN: 2321-4988November 18-19, 2013 T neurobiological basis of alcohol dependence, established pharmacotherapies for alcohol dependence, pharmacotherapies under investigation, and obstacles to treatment are discussed. Alcohol binds to hydrophobic pockets of proteins, changing their three-dimensional structure and their function. Proteins that are particularly sensitive to alcohol include ion channels, neurotransmitter receptors, and enzymes involved in signal transduction. Established pharmacologic treatments, notably disulfiram and naltrexone, combined with behavioral therapies, may reduce the amount of drinking, the risk of relapse, the number of days of drinking, and craving in some alcohol-dependent individuals. For many patients, however, these treatments are not effective. Recent advances in molecular and behavior genetics are guiding the development of new drugs; these efforts seek to identify pharmacologic pathways relevant to alcohol dependence and to more effectively match treatments to individuals according to their genetic characteristics. Efficacy and safety concerns for acamprosate have been satisfied; the drug was recently released for marketing in the United States. Medications such as sertraline, ondansetron, topiramate, and aripiprazole represent novel lines of research and are currently being tested for use in the treatment of alcoholism. Even with more efficacious medications, however, a transformation must occur in how alcoholism treatment is viewed, not only by the public but also by clinicians. Swetha Kusumba, J Pharmacovigilance 2013, 1:4 http://dx.doi.org/10.4172/2329-6887.S1.009Pharmaceutical care is a philosophy of practice that is being adopted by many pharmacists world-wide and is described as a practice in which the pharmacist takes responsibility for a patient’s drug-related needs and is held accountable for this commitment. Pictorials may be used to augment textual instructions in the depiction of safety and warning information on medicines. An inability to read and understand written medication instructions may be a major contributory factor to non-compliance in certain population. The use of visual aids such as pictograms in communicating health information to low-literate populations has been receiving increased attention over the past few years and this is accompanied by a growing body of literature on the subject. Although a detailed discussion is beyond the scope of this article, a review on the topic is available.