Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form

Shelke, Akash; Mankar, Someshwar; Kolhe, Mahesh

doi:10.52711/2349-2988.2021.00015

Cited by 4 publications

(1 citation statement)

References 6 publications

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“…It is official in Indian Pharmacopoeia 1 . The most commonly used techniques for determining SEC in pharmaceutical dosage forms are UV spectrophotometric [31][32] , HPLC [33][34][35] , supercritical fluid chromatography 36 and electrochemical method 37 . Other method has been performed to determine SEC in biological fluids, such as polarography 38 As per our knowledge, no derivative UV spectrophotometric method has been reported for simultaneous estimation of Azithromycin, Fluconazole and Secnidazole in tablet formulation.…”

Section: Secnidazole (Sec) Chemically Is (Rsmentioning

confidence: 99%

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

Raskar,

Kate,

Mungse

et al. 2023

J. Drug Delivery Ther.

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Two simple, sensitive, accurate and precise spectrophotometric methods were developed and validated for the quantitative determination of Azithromycin (AZI), Fluconazole (FLU) and Secnidazole (SEC) in bulk and tablet dosage form. Method A is based on the first-order derivative (D1) and Method B is based on the second-order derivative (D2) spectrophotometric method. In Method A, absorbance was measured at 215nm, 275nm and 333nm being the zero crossing points for AZI, FLU and SEC respectively. In Method B, absorbance was measured at 220nm, 225nm and 211nm being the zero crossing points for AZI, FLU and SEC respectively. For Method A, all three drugs obey Beer’s law in the concentration range 5-30µg/ml for AZI, 5-60 µg/ml for FLU and 5-40 µg/ml for SEC with correlation coefficients 0.995, 0.998 and 0.998 respectively. For Method B, all three drugs obey Beer’s law in the concentration range 5-35 µg/ml for AZI, 5-40 µg/ml for FLU and 5-40 µg/ml for SEC with correlation coefficients 0.995, 0.999 and 0.998 respectively. Both methods can be used for routine analysis of these three drugs in their pharmaceutical dosage form. Results for analysis of both methods were tested and validated for various parameters according to ICH guidelines. Keywords: Derivative, Azithromycin, Fluconazole, Secnidazole

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Section: Secnidazole (Sec) Chemically Is (Rsmentioning

confidence: 99%

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

Raskar,

Kate,

Mungse

et al. 2023

J. Drug Delivery Ther.

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Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Sen,

Ravindar,

Jala

et al. 2023

RJPT

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The present work describes the development of a simple, precise and accurate derivative spectroscopic and RP-HPLC method for the estimation of levofloxacin hemihydrate in the tablet dosage form. Levofloxacin hemihydrate showed absorption maxima at 287.36, 287.2 and 296.2nm in zero, first and second-order spectroscopic methods. The RP-HPLC method was optimized by using Orthophosphoric acid: acetonitrile: methanol (50: 20: 30) as solvent at 287nm. The methods showed linearity in the concentration range 1-5 and 2-10 µg/ ml and the correlation coefficient was 0.999 respectively. The method has been validated according to the ICH guidelines. The percentage relative standard deviation was found to be less than 2% in respect of both methods.

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Analytical Methods of Estimation of Oxetacaine and its quality determinations in different Pharmaceutical Formulations by Reverse Phase High Performance Liquid Chromatography (RP-HPLC)

N.,

M. S.,

2023

RJPT

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Objective: The aim of the current research was to design and develop an analytical method for the estimation of Oxetacaine and its quality control determinations of different formulation by reverse phase high performance liquid chromatography (RP-HPLC). Method: In Method I the Agilent HPLC used for the Estimation purpose. C-18 column (250 X 4.6mm i.e., 1µ) as stationary phase and 0.05% formic acid buffer: Methanol in the ratio 30:70 % v/v as mobile phase, with a flow rate of 1.0ml/min. Diluents of Methanol: water 90:10 ratio used for the study with ambient Temp conditions. In Method II the Agilent HPLC used for the Estimation purpose .C8 Column ((250 X 4.6mm i.e., 5µ) as stationary phase and ammonium phosphate buffer pH 4.8: Acetonitrile in the ratio 25:75 % v/v as mobile phase, with a flow rate of 0.9ml/min. Diluents of Acetonitryl: water 50:50 ratios used for the study with ambient Temp conditions. Result: Method 1: Oxetacaine standard (86µg/ml concentration) peak was eluted at average of 5.629min at 3 runs with Asymmetry of 1.29813 and Peak area of 23237896 with the conditions of %RSD of max2. With qualifying of system suitability, accuracy and reproducibility. Some of Marketed suspension formulations were operated under the same instrument conditions and the results were compared with standard Oxetacaine to ensure the percentage purity of Marketed suspensions. Method 2: Oxetacaine standard (196µg/ml concentration) peak was eluted at average of 4.884 min at 3 runs with Asymmetryof1.17244 and Peak area of 360543170 with the conditions of %RSD of max 2. With qualifying of system suitability, accuracy and reproducibility. Some of Marketed suspension formulations were operated under the same instrument conditions and the results were compared with standard Oxetacaine to ensure the percentage purity of Marketed suspensions. Conclusion: The two new method of estimation of oxetacaine like using Method 1: C18 column, 0.05% formic acid buffer: Methanol in the ratio 30:70 % v/v as mobile phase @214nm and Method 2: C8 Column, ammonium phosphate buffer pH 4.8: Acetonitrile in the ratio 25:75 % v/v as mobile phase @214 achieved with simple, precise, accurate and sensitive. In addition the quality control estimating of some of random of F1, F2, F3, F4, F5, and F6 marketed oxetacaine suspensions were analysed using this Two Optimized methods. Out of 6 formulations, 2 formulations F3, F6 determined as substandard quality on the both the methods. Hence proving these two new methods optimal for the further monograph inclusions as well as quality control predictions of oxetacaine in API as well as Finished Pharmaceutical Formulations.

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Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form

Cited by 4 publications

References 6 publications

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Analytical Methods of Estimation of Oxetacaine and its quality determinations in different Pharmaceutical Formulations by Reverse Phase High Performance Liquid Chromatography (RP-HPLC)

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