A green analytical method for the simultaneous estimation of Levofloxacin hemihydrate and ambroxol hydrochloride using hydrotropy and first derivative UV spectroscopy

In this study, three simple and accurate spectrophotometric methods for simultaneous determination of pyriproxyfen and chlorothalonil residues in cucumbers and cabbages grown in experimental greenhouse were studied. The first method was based on the zero-crossing technique measurement for first and second derivative spectrophotometry. The second method was based on the first derivative of the ratio spectra. However, the third method was based on mean centering of ratio spectra. These procedures lack any previous separation steps. The calibration curves for three spectrophotometric methods are linear in the concentration range of 1–30 μg·mL−1 and 0.5–7 μg·mL−1 for pyriproxyfen and chlorothalonil successively. The recoveries ranged from 82.12–97.40% for pyriproxyfen and 81.51–97.04% for chlorothalonil with relative standard deviations less than 4.95% and 5.45% in all instances for pyriproxyfen and chlorothalonil, respectively. The results obtained from the proposed methods were compared statistically by using one-way ANOVA, and the results revealed there were no significant differences between ratio spectra and mean centering methods with the zero-crossing technique. The proposed methods are successfully applied for the simultaneous estimation of the residue of both pesticides in cucumber and cabbage samples.

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A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00949 ◽

2021 ◽

pp. 5443-5448

Author(s):

Punna Venkateshwarlu ◽

Mehul M. Patel

Keyword(s):

Liquid Chromatography ◽

Anticancer Drugs ◽

Analytical Method ◽

Analytical Methods ◽

Bioanalytical Methods ◽

Method Development ◽

Estimation Methods ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Forms ◽

Stability Indicating

This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.

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DETERMINATION OF TELMISARTAN HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE IN BINARY MIXTURE AND PHARMACEUTICAL TABLET DOSAGE FORM BY FIRST DERIVATIVE RATIO SPECTROPHOTOMETRIC METHOD

INDIAN DRUGS ◽

10.53879/id.53.11.10579 ◽

2016 ◽

Vol 53 (11) ◽

pp. 57-64

Author(s):

V Thakur ◽

◽

S. J. Daharwal

Keyword(s):

Binary Mixture ◽

Spectrophotometric Method ◽

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

First Derivative ◽

Pharmaceutical Tablet ◽

Study Results ◽

Recovery Study ◽

Tablet Dosage

New first derivative ratio spectrophotometric method was developed for simultaneous estimation of telmisartan hydrochloride (TELM) and hydrochlorothiazide (HCTZ) in combined tablet dosage form without prior separation. The amplitude in the first derivative of the corresponding ratio spectra at 263.2 nm and 278.4 nm of TELM and for HCTZ at 287.2 nm and 304.8 nm were selected for the determination. The calibration graphs were established in the range of 1-10μg/mL and 2-15 μg/mL of TELM and HCTZ, respectively. The percentage recoveries of binary mixture of TELM were found to be 97.81±1.05 (263.2nm) and 96.60±1.91 (278.4nm) and for HCTZ were found to be 97.47±1.41 (287.2), 98.16± 1.45 (304.8nm) by proposed method. This method was successfully applied for the analysis of commercial tablet formulation, with no interference from excipients as indicated by the recovery study results. The proposed method was validated, statistically analyzed, compared with reported HPLC method and can be successfully applied for the routine analysis.

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DEVELOPMENT OF STABILATING INDICATING ANALYTICAL METHOD FOR FAMOTIDINE AND DICLOFENAC POTASSIUM IN COMBINED DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.49.06.p0040 ◽

2012 ◽

Vol 49 (06) ◽

pp. 40-42

Author(s):

D. R. Chaple ◽

◽

S. A Mehta ◽

M. P Yeole ◽

P. S. Tarte

Keyword(s):

Analytical Method ◽

Dosage Form ◽

Simultaneous Equation ◽

Routine Analysis ◽

Simultaneous Estimation ◽

Tablet Dosage

This work deals with the simultaneous estimation of famotidine and diclofenac potassium in a tablet dosage form. The method employed is simultaneous equation. The absorption maxima at 266 nm and 286 nm were used for the estimation of famotidine and diclofenac, respectively. Both the drugs and their mixture obey Beer-Lamberts law at selected wavelength in given concentration range. The result of analysis has been validated statistically and recovery studies confirmed the accuracy of the proposed method. The proposed method is simple, rapid, precise and accurate. It is used for the routine analysis of both drugs.

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DEVELOPMENT AND VALIDATION OF BIOANALYTICAL HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND NEBIVOLOL IN HUMAN PLASMA

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2017v9i10.20237 ◽

2017 ◽

Vol 9 (10) ◽

pp. 253

Author(s):

Aruna G. ◽

Bharathi K ◽

Kvsrg Prasad

Keyword(s):

Human Plasma ◽

Analytical Method ◽

Internal Standard ◽

Hplc Method ◽

Pharmacokinetic Parameters ◽

Simultaneous Estimation ◽

Time Data ◽

Bioanalytical Method Validation ◽

Limit Of Quantitation ◽

The Mean

Objective: To develop and validate a modified isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method for determination of cilnidipine and nebivolol in human plasma to be used for pharmacokinetic studies.Methods: The drug was extracted from plasma samples by direct protein precipitation technique using acetonitrile. Amlodipine was used as internal standard (IS). Samples were analyzed on BDS C18 column (250 x 4.6 mm, 5 µm), applying ortho phosphoric acid (0.1%): Acetonitrile, at a ratio of 45:55 v/v in isocratic mode as a mobile phase at a flow rate of 1 ml/min to attain adequate resolution. Separations were performed at room temperature and monitored at a wavelength of 260 nm after injection of 50μl samples into the HPLC system. The analytical method was validated according to FDA bioanalytical method validation guidance. The method was applied for pharmacokinetic study of cilnidipine and nebivolol tablets-10 mg and 5 mg were administered as a single dose to 6 healthy male rabbits under fasting condition. Twelve blood samples were withdrawn from each rabbit over 24 h periods. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax, Tmax, AUC0-t and AUC0-∞ were calculated.Results: A peak area was obtained for cilnidipine and nebivolol at 3.943 and 4.719 min retention time respectively. Linearity was established at a concentration range of 0.20-20 μg/ml (r2=0.999, n=8) for cilnidipine and 0.02-2 μg/ml (r2=0.999, n=8) for nebivolol. The lower limit of quantitation (LLOQ) was identifiable and reproducible at 0.2μg/ml for cilnidipine and 0.02 μg/ml for nebivolol. The coefficients of variation (%cv) of the intra-day and inter-day precision of cilnidipine at 600, 1000 and 1600ng/ml levels were found to be 6.90%, 6.19%, 5.22%; and 7.74%, 6.54%, 5.77%, respectively, which are lower than the accepted criteria limits (15-20 %). The mean recovery (%) cilnidipine at 600, 1000, and 1600ng/ml was found to be 101.03%, 99.27% and 104.87%, and for nebivolol 60, 100, and 160 ng/ml was found to be 106.13%, 107.03% and 98.06% respectively. Stability at different conditions and in autosampler was also established. The mean pharmacokinetic parameters; Cmax, Tmax, AUC0-t and AUC0-∞ were 6 ng/ml, 2 hr, 96.76 mg. hr/ml, 63.45 mg. hr/ml for cilnidipine and 5.8ng/ml, 2hr, 74.78 mg. hr/ml, 100.25 mg. hr/ml for nebivolol respectively.Conclusion: The present analytical method was found to be specific, sensitive, accurate and precise for quantification of cilnidipine and nebivolol in human plasma. It can be successively applied for pharmacokinetics, bioavailability and bioequivalence studies.

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