International Journal of Advances in Pharmaceutical Analysis
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A validated RP-HPLC method for simultaneous determination of Metformin HCl and Vildagliptin in pharmaceutical formulation
Get PDFA selective and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the separation and quantification of metformin HCl (MET) and vildagliptin (VILD) in tablet dosage form. The determination was carried out using phenomenax C18 column (4.6150 mm) as a stationary phase and mobile phase comprised of phosphate buffer (pH6.0): methanol (65:35v/v). The pH of phosphate buffer is adjusted to 6.0 by using orthophosphoric acid. The flow rate was maintained at 1.0ml/min and the eluent was monitored at 255nm.The retention time of MET and VILD were 1.503 min and 5.530 min respectively. The method was validated in terms of linearity, precision, accuracy, ruggedness, specificity and robustness. The method was linear over the range 50-150 g/ml for both MET (r = 0.999) and VILD (0.998). For precision studies; RSD for MET and VILD were 0.24 and 0.14 respectively. The percentage recoveries for both drugs from their tablets were 100.16 and 99.98 respectively. Inter-day; intra-day RSD for both drugs were found be 0.27 and 0.26, 0.13 and 0.29 respectively
Development and validation of an RP-HPLC method for determination of Cefixime and Dicloxacillin in tablet dosage form
Get PDFA simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Cefixime and Dicloxacillin in bulk drug and tablet dosage form. Sepration was achieved by capcell pack C-18 column having 250 mm4.6 mm i.d. in isocratic mode, with mobile phase containing 0.05 M potassium dihydrogen phosphate: methanol (25:75), adjusted to pH 4.5 using ortho phosphoric acid. The flow rate was 1.0 ml/min and effluents were monitored at 232 nm. The retention time of Cefixime and Dicloxacillin were 3.19 min and 6.68 min respectively. The linearity for Cefixime and Dicloxacillin were in the range of 10-100 g/ml. The recoveries of Cefixime and Dicloxacillin were found in the range of 99.63-99.95 % and 99.58-99.98 % respectively. The proposed method was validated as per ICH and USP guidelines and successfully applied to the estimation of Cefixime and Dicloxacillin in bulk drug and tablet dosage form
A Review: Application and experimental designs of experiments for analysis of various organic compounds using GC-MS
Get PDFGas chromatography ("GC") and mass spectrometry ("MS") make an effective combination for chemical analysis. This article serves to demonstrate tools for an effective attack or defence of GC/MS evidence. The GC device is generally a reliable analytical instrument.The GC instrument is effective in separating compounds into their various components. However, the GC instrument cannot be used for reliable identification of specific substances. The MS instrument provides specific results but produces uncertain qualitative results. When an analyst uses the GC instrument to separate compounds before analysis with an MS instrument, a complementary relationship exists. The technician has access to both the retention times and mass spectral data. Many scientists consider GC/MS analysis as a tool for conclusive proof of identity. GC/MS analysis, where the effluent to the GC instrument is the feed to the MS instrument, is in wide use for confirmation testing of substances. Drug testing, manufacturing quality control and environmental testing are some typical uses
Review article on COMPARATIVE STUDY OF NEW TRENDS IN HPLC
No full textThis article represents a brief review of HPLC along with its principle and instrumentation. It describes about new trends in HPLC such as RRLC, UPLC , UFLC and Nano LC. In this article mainly focus on detailed comparison of new developments of HPLC in terms of instrumental operating conditions, applications and advantages over HPLC of each technique
FOURIER TRANSFORM- ION CYCLOTRON MASS RESONANCE SPECTROSCOPY
Get PDFMass spectrometry is essentially a technique for "weighing" molecules. Mass spectrometry is based upon the motion of a charged particle, called an ion, in an electric or magnetic field. Mass spectrometry relies on the formation of gas-phase ions (positively or negatively charged) that can be isolated electrically (or magnetically) based on their mass-to-charge ratio ( m/z ). Where as in Fourier transform ion cyclotron mass resonance spectroscopy(FTICR-MS) the m/z ratio measurement of an ion is based upon the ion's motion or cyclotron frequency in a magnetic field. Ions are detected by passing near detection plates and thus differently from other mass detectors/analysers in which ions are hitting a detector (at different times or places),The ions are trapped in a magnetic field combined with electric field perpendicular to each other (Penning trap). They are excited to perform a cyclotron motion. The cyclotron frequency depends on the ratio of electric charge to mass (m/z) and strength of the magnetic field.This spectrometric analysis can provide important information about the analytes, including their structure, purity, and composition
DETERMINATION OF ATORVASTATINE IN PHARMACEUTICAL FORMULATIONS BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Get PDFA 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
DETERMINATION OF ATORVASTATIN CALCIUM IN PHARMACEUTICAL FORMULATIONS BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Get PDFA 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.
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF TOLPERISONE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Get PDFA rapid, specific and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for the determination of Tolperisone Hydrochloride (TOLP) in bulk and tablet dosage form. The method involved an isocratic elution of TOLP on C 18 column (250 X 4.6 mm,
FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF METFORMIN HYDROCHLORIDE ON LABORATORY SCALE
No full textThe 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
STABILITY STUDY: REGULATORY REQUIRENMENT
Get PDFStability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions