Simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form by absorption ratio method using UV-Vis spectrophotometry

A simple, precise, reproducible, accurate, economical and rapid UV-VIS Spectrophotometric method have been developed and validated for the simultaneous estimation of ATN and CTN in tablet dosage form. This paper describes the absorption ratio method as a quantification parameter. The absorption ratio method (ARM) involves measurement of absorbance of sample solution is measured at 240.0 nm (Isobestic Point) and 251.0 nm (? max of CTN) and based on E 1% 1cm values at these wavelengths two set of equations were framed. The developed method obeys the beers law in the concentration range of 40-80g/mL for ATN and 10-50 g/mL for CTN. The recovery studies shows %RSD for ATN 0.21 and for CTN 1.34 by ARM method. The results of analysis have been validated statistically for accuracy, precision, repeatability, specificity and ruggedness. The method was successfully applied to the determination of these drugs in pharmaceutical dosage form

DETERMINATION OF ATORVASTATIN CALCIUM 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 in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ, Waters symmetry column. The flow rate was 1ml/min and eluent was monitored by absorbance at 246 nm using a mixture of Methanol and Acetonitrile (pH 3.

DETERMINATION OF TELMISARTAN AND FORCED DEGRADATION BEHAVIOR BY RP-HPLC IN TABLET DOSAGE FORM

A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ, Waters symmetry column in gradient mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.

FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF METFORMIN HYDROCHLORIDE ON LABORATORY SCALE

The purpose of this research is to prepare metformin hydrochloride immediate release tablets by wet granulation technique. In order to obtain the best, optimized product ten different formulations were developed. Different binder, disintegrants and lubricants taken as variables. Weight variation, thickness, hardness, friability, disintegration time, in-vitro release and pharmaceutical assay were studied as response variables. Capping was observed in formulation containing PVP K-30. However, in the remaining formulation containing PVP K-90, no capping was observed. The formulation A7 was selected as optimized formulation. The different physical properties and in-vitro release profile showed best comparable with the reference product. Optimization has proven an effective tool in product development

Review: Ion mobility spectroscopy a new method of analysis, its application and reproducibility problems

Ion Mobility Spectrometry (IMS) is a mass-selective technique in which the sample is vaporised, ionised, and with given initial velocity moved along a drift region towards a collector electrode. The drift times (milliseconds, ms) needed by the ions to reach the collector are proportional to their masses: the higher the mass, the longer the drift times. During our evaluation of ion mobility spectrometry in the screening it was found that reproducibility problem may occurred which is solve easily by using some methods, described in this review. Ion mobility spectroscopy is widely use for the drug analysis, hair analysis and other applications

STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF TELMISARTAN IN THE DOSAGE FORM

A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for quantitative analysis of Telmisartan (TELM) in pharmaceutical dosage forms. Chromatographic separation of TELM and its degradation products was achieved on a C18, 250 × 4.6 mm, 5μ, Waters symmetry column

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

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

Bioanalytical method development and validation

Bioanalytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like saliva, urine, plasma, serum. Development and validation of bioanalytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Bioanalytical method development consists of three essential interrelated parts sample preparation, chromatographic separation and detection by using proper analytical method. Validation of a Bioanalytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bioanalytical application. The validation is further divided into 3 segments full validation, partial validation, and cross validation each of which has its own purpose. This review describes mainly the various aspects for development of bioanalytical method and for the validation of bioanalytical methods. Also the Bioanalytical method transfer is also described

Development of validated stability indicating assay method for the simultaneous estimation of hydrochlorothiazide Amlodipine besylate and Losartan potassium in combine dosage form

A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of HCTZ, LOSA and AMLO was developed. The chromatographic assay involves the use of SUPELCO LC-8-DB column (15 cm x 4.6 mm, 5 m) with a simple mobile phase composition of Buffer (monobasic Potassium Dihydrogen phosphate of 0.025 M having pH 3.7): Acetonitrile (60:40) at a flow rate of 1mL/min with U.V detection at wavelength of 232 nm. The method showed good linearity in the concentration range of 4-40 ?g/mL for HCTZ and 2-22 ?g/mL for AMLO and 15-150 ?g/mL for LOSA. The proposed method was also successfully applied to 20 tablets of marketed formulation (Trilopace). The developed method was successfully validated as per the ICH guidelines for following parameters. Accuracy, precision, ruggedness, robustness, system suitability tests, etc. The RSD for system precision was found to be 0.89-0.49 for HCTZ, AMLO, and LOSA and for method precision 1.0-1.4 for HCTZ, AMLO, and LOSA. The average percentage recoveries 99.75, 99.88, 98.93 for HCTZ, AMLO, LOSA 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), , Oxidative (3% H 2 O 2 ), Thermal (80 0 C