9 research outputs found

    Pharmaceutical Analysis of Eptifibatide via Simple, Rapid, Economical UV-Spectrophotometric Methods

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    Eptifibatide is an antiplatelet drug of the glycoprotein IIb/IIIa inhibitor class. Pharmaceutically it is applied to reduce the risk of acute cardiac ischemic events. The present work reveals two simple, rapid and economical UuV-Spectrophotometric methods for pharmaceutical analysis of Eeptifibatide bulk and in parenteral formulation. The ‘Method I’ is based on the Zero Order Spectrophotometric determination of drug at its wavelength maximum 218.20 nm and ‘Method II’ employed First Order Derivative - Aarea Uunder Curve (AUauC) technique in which the area has been integrated between two wavelengths 220.20 to 237.20 nm. The drug obeyed linearity in the concentration range of 3 - 18 μg/mLl with coefficient of correlation; greater than 0.999 in both methods. The amounts of drug determined by both methods are in conformity with label claim. These methods are validated for accuracy, precision and ruggedness with % RSD value less than 2.0

    Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Quinfamide and Mebendazole in in-house Pharmaceutical Formulation

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    The present work described the development of two simple, accurate, rapid, cost effective and reproducible UV-Spectrophotometric methods for the simultaneous estimation of Quinfamide and Mebendazole in bulk and in laboratory mixture using 0.01M methanolic HCl as a solvent. The absorption maximum for Quinfamide and Mebendazole were found to be at 260.00 nm and 232.40 nm respectively. Beer’s - lamberts was followed in concentration ranges of 1 - 6 μg/mL for Quinfamide and 2- 12 μg/mL for Mebendazole. The percentage recovery of Quinfamide and mebendazole ranged from 98.48 to 99.08 and 98.83 to 99.62 (Method I); from 98.14 to 98.93 and 99.16 to 99.35 (Method II) for Quinfamide and Mebendazole. The established methods were sensible for simultaneous quantitative determination of both these drugs in fixed dose combinations. Validation of both these methods was performed as per ICH guidelines. The developed methods can routinely be used for estimation of both these drugs in their combined dosage form

    An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker

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    BF is Beta-adreno receptor antagonist and used as an AntiHypertensive Drug. BF gives the blocking action on β1-adrenergic receptors in the heart and vascular smooth muscle. The present review compiles the various approaches implemented for quantification of BF in bulk drug, pharmaceutical matrix and biological fluid. This review represents more than 50 analytical methods which include capillary electrophoresis, HPLC, HPTLC, UV-Spectroscopy, UPLC, impurity profiling and electrochemical methods implemented for estimation of BF as a single component as well as in multicomponent

    Novel HPTLC and UV-AUC analyses: For simple, economical, and rapid determination of Zileuton racemate

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    Novel, simple, rapid and reliable High-Performance Thin-Layer Chromatographic (HPTLC) and UV-spectroscopic area under curve (UV-AUC) methods were developed and validated for the analysis of zileuton racemate in bulk and in in-house tablet formulation. HPTLC quantitation of zileuton was done by UV detection at 260 nm and analysis was performed on (20 × 10 cm) aluminium sheets precoated with silica gel 60-F254 (E. Merck) as stationary phase and toluene–methanol–glacial acetic acid (3.5:1.5:0.1 v/v) as mobile phase. Quantitation by HPTLC method was performed over the concentration range of 200–1200 ng/band. The HPTLC method resulted into a compact and well resolved band for zileuton at retention factor (Rf) of 0.51 ± 0.02. Linear regression analysis data for calibration of HPTLC method represented a good linear relationship with regression coefficient; r2 = 0.997. UV-AUC method was developed using sodium lauryl sulphate (0.05 M) as a hydrotropic agent to enhance water solubility and area was determined at a wavelength range in between 248.40 and 271.0 nm. Correlation coefficient for UV-AUC analysis was found to be r2 = 0.999. The developed UV-AUC method depicted a fine linear relationship for zileuton racemate in a concentration range of 2–12 μg/mL. Both the developed methods were validated for precision, robustness, ruggedness, accuracy, sensitivity as per guidelines laid by the International Conference on Harmonisation (ICH). Statistical analysis proved that the developed methods were precise, robust, sensitive and accurate and can be used effectively for the analysis of zileuton in bulk and pharmaceutical formulations

    Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination

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    A simple, rapid, sensitive, robust, stability-indicating RP-HPLC-PDA analytical protocol was developed and validated for the analysis of zileuton racemate in bulk and in tablet formulation. Development of method and resolution of degradation products from forced; hydrolytic (acidic, basic, neutral), oxidative, photolytic (acidic, basic, neutral, solid state) and thermal (dry heat) degradation was achieved on a LC – GC Qualisil BDS C18 column (250 mm × 4.6 mm × 5 μm) by isocratic mode at ambient temperature, employing a mobile phase methanol and (0.2%, v/v) orthophosphoric acid in ratio of (80:20, v/v) at a flow rate of 1.0 mL min−1 and detection at 260 nm. ‘Design of Experiments’ (DOE) employing ‘Central Composite Design’ (CCD) and ‘Response Surface Methodology’ (RSM) were applied as an advancement to traditional ‘One Variable at Time’ (OVAT) approach to evaluate the effects of variations in selected factors (methanol content, flow rate, concentration of orthophosphoric acid) as graphical interpretation for robustness and statistical interpretation was achieved with Multiple Linear Regression (MLR) and ANOVA. The method succeeded over the validation parameters: linearity, precision, accuracy, limit of detection and limit of quantitation, and robustness. The method was applied effectively for analysis of in-house zileuton tablets

    A Precise Review on Tenofovir Disoproxil Fumarate: An Analytical Profile

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    Tenofovir Disoproxil Fumarate (TDF) is antiretroviral medicine used treat AIDS as well as chronic Hepatitis-B. TDF is a prodrug of tenofovir and exists as dominant form due to lesser oral bioavailability of parent drug. TDF is now available in a fixed-dose combination with various antiretrovirals like Cobicistat, Efavirenz, Elvitegravir, Emtricitabine, Lamivudine, Rilpivirine, and Nevirapine. Hence, pharmaceutical analysis of TDF and applicability of different analytical methods have gained crucial importance. The present review article assesses the published analytical methods and a variety of approach for investigation of TDF in bulk drug as well as pharmaceutical formulations including combinations. This detailed review includes examination of around eighty analytical methods published during 2008 to 2016 using various techniques which include HPLC, HPTLC, and UV/ Visible-Spectrophotometry. The review also illustrates the scope and limitations of many published analytical methods for analysis of TDF. Such detailed review will be of great help to the researcher who is working on TDF. Miscellaneous methods of rare but unique pharmaceutical distinction have also been given due consideration. The diagrammatic illustrations provide the statistical overview about the various methods referred for analysis of TDF