DETERMINATION OF ATORVASTATINE IN PHARMACEUTICAL FORMULATIONS BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

A simple, sensitive and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative estimation of Atorvastatin calcium (ATOR-C) in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 4.6 mm, 5?, Waters symmetry column. The flow rate was 1mL/min and eluent was monitored by absorbance at 246.0 nm using a mixture of Methanol and Acetonitrile (pH 3.00.01) in the ratio of 25:75 (v/v). The retention times of ATOR-C was found to be 5.5 min. Calibration plots were linear in the concentration range of 5-25 ?g/mL for ATOR-C calcium. The total run time was 12 min. The proposed method was validated by testing its linearity, recovery, specificity, system suitability, precision (Interday, intraday, analyst and instrument precision), robustness and LOD/LOQ values and it was successfully employed for the determination of ATOR-C in pharmaceutical tablet formulations

Recent approaches for impurity profiling of pharmaceuticals

Impurities must be monitored carefully to assure the quality of drugs. It is important to identify potential sources of such impurities. Selective analytical methods need to be developed to monitor them. Methodology aspects for impurity investigations are discussed along with an emphasis on understanding the origin and fate of impurities to guide decisions on process controls and specifications. Orthogonal analytical approaches for impurity investigations to provide a complete understanding of a drug substance impurity profile. Considerations for control of toxic impurities include sensitive and selective analytical methodology and determination of the process capability for removing the impurity. New impurities may be observed as changes are made in the synthesis, formulation, or production procedures, albeit for improving them. At times it is necessary to isolate and characterize an impurity when hyphenated methods do not yield the structure or when confirmation is necessary with an authentic material

Review: Development of forced degradation studies of drugs

Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms

Development of validated stability indicating assay method for simultaneous estimation of Diclofenac Sodium and Misoprostol in their combined dosage form

A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of DF and MP was developed. The chromatographic assay involves the use of Hi Q C18 W, 150 x 4.6mm, 5m column with a simple mobile phase composition of Acetonitrile and HPLC Grade water in the ratio of 70:30%v/v at a flow rate of 1mL/min with U.V detection at wavelength of 220 nm. The method showed good linearity in the concentration range of 50-100 ?g/mL for DF and 0.20-0.40 ?g/mL for MP. The proposed method was also successfully applied to 20 tablets of marketed formulation (Arthotec). The developed method was successfully validated as per the ICH guidelines for following parameters. Accuracy, precision, repeatability, ruggedness, robustness, system suitability tests, etc. The RSD for Intra-day and Inter-day precision was found to be 0.96-1.85, 1.02-1.83 For DF and 0.55-0.59, 0.59-0.63 for MP. The average percentage recoveries for DF were found to be 90.83, 99.74, 100.21 and for MP it was found to be 100.83, 98.94, 99.72. which was in good agreement with labeled amount of Pharmaceutical formulation. The stability indicating capacity was tested by accelerated degradation of marketed formulation in acidic (0.1 N HCl), basic (0.1 N NaOH), Neutral (water), Oxidative (3% H 2 O 2 ), Thermal (60 0 C), Sunlight exposure

Phyllanthus Niruri: A magic Herb

Medicinal herbs are significant source of pharmaceutical drugs. Latest trends have shown increasing demand of phytodrugs and some medicinal herbs have proven hepatotprotective potential. Inflammation describes a coordinated series of molecular, cellular, tissue, organ, and systemic responses that drive the pathology of various diseases Inflammation is a finely tuned, dynamic, highly-regulated process that is not inherently detrimental, but rather required for immune surveillance, optimal post-injury tissue repair, and regeneration. The inflammatory response is driven by cytokines and chemokines and is partially propagated by damaged tissue-derived products (Damage-associated Molecular Patterns; DAMP’s). DAMPs perpetuate inflammation through the release of proinflammatory cytokines, but may also inhibit anti-inflammatory cytokines

Standardisation Of Marketed Herbal Fromulation Of Muscle And Joint Hrx Pain Relieving Oil

Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms

5-Aminolevulinic Acid as a Novel Therapeutic for Inflammatory Bowel Disease

5-Aminolevulinic acid (5-ALA) is a naturally occurring nonprotein amino acid licensed as an optical imaging agent for the treatment of gliomas. In recent years, 5-ALA has been shown to possess anti-inflammatory and immunoregulatory properties through upregulation of heme oxygenase-1 via enhancement of porphyrin, indicating that it may be beneficial for the treatment of inflammatory conditions. This study systematically examines 5-ALA for use in inflammatory bowel disease (IBD). Firstly, the ex vivo colonic stability and permeability of 5-ALA was assessed using human and mouse fluid and tissue. Secondly, the in vivo efficacy of 5-ALA, in the presence of sodium ferrous citrate, was investigated via the oral and intracolonic route in an acute DSS colitis mouse model of IBD. Results showed that 5-ALA was stable in mouse and human colon fluid, as well as in colon tissue. 5-ALA showed more tissue restricted pharmacokinetics when exposed to human colonic tissue. In vivo dosing demonstrated significantly improved colonic inflammation, increased local heme oxygenase-1 levels, and decreased concentrations of proinflammatory cytokines TNF-α, IL-6, and IL-1β in both plasma and colonic tissue. These effects were superior to that measured concurrently with established anti-inflammatory treatments, ciclosporin and 5-aminosalicylic acid (mesalazine). As such, 5-ALA represents a promising addition to the IBD armamentarium, with potential for targeted colonic delivery

STUDIES ON BIOAVAILABILITY ENHANCEMENT OF CURCUMIN

Objective: The objective of the present work was to improve aqueous solubility and in vivo bioavailability of curcumin and structural analogues of curcumin such as potassium, calcium, magnesium salts and nitro derivative. Methods: Structural analogues of curcumin were prepared by reaction of curcumin with potassium chloride, magnesium chloride hexahydrate and calcium chloride dihydrate in a suitable solvent. The nitro derivative synthesized by treating curcumin with sulphuric acid and nitric acid. The prepared analogues were evaluated for melting behavior, solubility, UV spectrophotometry, partition coefficient, moisture content, cellular uptake, FTIR analysis, antimicrobial activity and in vivo bioavailability in the rat. Results: Chemical modification of curcumin increased the saturation solubility to 11.6, 16.5, 21.5, 28.0 µg/ml in calcium salt, magnesium salt, potassium salt and nitro derivative respectively, against 8.6 µg/ml of curcumin. The analogues were chemically stable as curcumin analyzed by FTIR spectrophotometry. Increased cellular uptake, as well as enhanced antimicrobial activity, was demonstrated by modified curcumin analogues. Moreover, significant improvement in plasma levels was estimated with nitro derivative. Conclusion: The present work recommends that nitration of curcumin improves aqueous solubility which may improve absorption and in vivo bioavailability

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy