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Pharmaceutical Analysis Articles


RP-HPLC METHOD FOR THE ESTIMATION OF NITAOXANIDE IN PHARMACEUTICAL FORMULATION

ABOUT AUTHORS:
R.Meera1*, N.Swathylakshmi2, M.Sundarapandian2, P.Raja Soundara Pandian1, Madhavanmallayasamy1
1Researcher, Radianz Health Care Pvt Ltd, Madurai, Tamilnadu, India
2Department of pharmaceutical Chemistry, K.M.College of pharmacy, Uthangudi, Madurai, India
meeraharsa23@gmail.com

ABSTRACT
Objective
: A simple and precise RP-HPLC method was developed and validated for the determination of Nitaoxanide in pharmaceutical dosage forms.
Materials and Methods
: Chromatography was carried out using waters RP –C18 150×4.6 mm, 3.5 µ, pH 6.8, buffer: acetonitrile (50:50) as the mobile phase at a flow rate 1.2 ml/min. The analyze was monitored using PDA detector at 254 nm. The proposed method was found to have linearity in the concentration range of 25-150µg/ml with correlation co efficient of r2 =0.9999.
Results:
The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for Nitaoxanide were in the range 100.06-101.9%.
Conclusion:
Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining Nitaoxanide in bulk and dosage forms.


SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF NITAOXANIDE IN BULK DRUG AND ITS PHARMACEUTICAL FORMULATION

ABOUT AUTHORS:
R.Meera1*, N.Swathylakshmi2, M.Sundarapandian2, P.Raja Soundara Pandian1, Madhavanmallayasamy1
1Researcher, Radianz Health Care Pvt Ltd, Madurai, Tamilnadu, India
2Department of pharmaceutical chemistry, K.M.College of pharmacy, Uthangudi, Madurai, India
meeraharsa23@gmail.com

ABSTRACT
Objectives
:
A simple spectrophotometric method was developed and validated for the determination of Nitaoxanide in pharmaceutical dosage forms. Two visible spectrophotometric methods have been described for the assay of Nitaoxanide bulk form or dosage forms.
Methods:
Method A is based on the formation of Schiff’s base and it was condensed with 4 hydroxybenzaldehyde. Method B is based on diazotization and coupling method with phluroglucinol. The methods are done in UV Visible spectrophotometric method having maximum absorbance at 460 nm.
Results:
Regression analysis of Beers law plots showed good concentration range of 10-50µg/ml for method A and B and gives reproducible results.
Conclusion
: Due to its simplicity of the method it may be used for determining Nitaoxanide in bulk and dosage forms.


A REVIEW ON ANALYTICAL METHODS FOR DETERMINATION OF LEVOSULPIRIDE IN PHARMACEUTICAL DOSAGE FORMS AND BIOLOGICAL SAMPLE

ABOUT AUTHORS:
Monika A. Rana*, Hasumati A. Raj
Department of Quality Assurance
Shree Dhanvantary College of Pharmacy,
Kim, Gujarat, India
monika92rana@gmail.com

ABSTRACT
Levosulpiride is an atypical antipsychotic agent. Levosulpiride is the levo enantiomer of sulpiride. It is a substitute benzamide which is meant to be used for several indications: depression, psychosis, somatoform disorders, emesis anddyspepsia. It blocks the presynaptic dopaminergic D2 receptor. Chemically it is N-[[(2S)-1-Ethylpyrrolidin-2-yl] methyl]-2-methoxy-5 sulfamoylbenzamide. several method such as HPLC in human plasma, area under curve, stability by RP-HPLC is done. The parent drug is given in a dose of 400-1800 mg orally. According to literature survey study of impurity profiling of LIVOSULPIRIDE in presence of intermediate has not been reported.


A REVIEW OF ANALYTICAL METHODS FOR DETERMINATION BROMHEXINE HYDROCHLORIDE IN PHARMACEUTICAL AND BIOLOGICAL SAMPLES

ABOUT AUTHORS:
Meera V. Lad1*, Vineet Jain2, Hasumati Raj1
1Department of Quality Assurance,
2Department of Pharmacognosy,
Shree Dhanvantary Pharmacy College, Kim, Gujarat
meeralad235@gmail.com

ABSTRACT:
Bromhexine HCl (BRH)is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus, chemically named 2-amino-3,5-dibromo-N-cyclohexyl-N-methyl benzenemethanamine hydrochloride. According to IUPAC it is 2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl] aniline hydrochloride. Because of its physiological importance, the drug has been quantified by exploiting its chemical  and physical properties. Bromhexine is a weak base and its precipitate out at pH value above 6. Bromhexine is a synthetic benzyl amine derivative ofvasicine. The different analytical methods used to quantify the drug as a single active pharmaceutical ingredient include flow injection analysis with ionselectiveelectrodes, inductively coupled plasma mass spectrometry, electrokinetic chromatography, electrochemical oxidation at the glassy carbon electrode, liquid chromatography, liquid gas chromatography, GC with mass detection, and voltammetry. The drug has also been quantified in its combined formulations using HPLC, direct and derivative UV spectrophotometry.


A REVIEW: ANALYTICAL METHODS FOR DETERMINATION OF CILNIDIPINE IN BIOLOGICAL FLUID AND PHARMACEUTICAL DOSAGE FORMS

ABOUT AUTHORS:
Farhana V. Buchiya*, Vineet Jain, Hasumati Raj
Shree Dhanvantary Pharmacy College,
Kim, Surat, Gujarat
buchiyafarhana22@gmail.com

ABSTRACT:
Cilnidipine is act as a  dual blocker by blocking L- type of calcium channel  present in vascular smooth muscles and  N- type of calcium channel  present in sympathetic nerve  terminal that supply  blood  vessels. Cilnidipine used in treatment of mostly in hypertension and various cardiovascular diseases except in Angina. Cilnidipine used alone or in combination. This review covers most recent analytical methods such as various spectroscopic methods, chromatographic methods and other methods for determination of cilnidipine in various pharmaceutical dosage forms and biological matrix were reported.


DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF SILDENAFIL CITRATE AND DAPOXETINE HYDROCHLORIDE IN THEIR COMBINED DOSAGE FORMULATION

ABOUT AUTHORS
Chetan A. Prajapati, Bhavik S. Patel
Department of Quality Assurance, Shri Sarvajanik Pharmacy College
Nr. Arvind Baug, Mehsana, Gujarat, India
prajapatichetan25@gmail.com

ABSTRACT
A simple, accurate and precise spectrophotometric method has been developed for simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in combined dosage form. Simultaneous equation method is employed for simultaneous determination of Sildenafil Citrate and Dapoxetine Hydrochloride from combined dosage forms. In this method, the absorbance was measured at 291 nm for Sildenafil Citrate and 230nm for Dapoxetine Hydrochloride. Linearity was observed in range of 6-42μg/ml and 2-10μg/ml for Sildenafil Citrate and Dapoxetine Hydrochloride respectively. Recovery studies confirmed the accuracy of proposed method and results were validated as per ICH guidelines. The method can be used for routine quality control of pharmaceutical formulation containing Sildenafil Citrate and Dapoxetine Hydrochloride.


DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF MANIDIPINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

ABOUT AUTHORS
Bhavik S. Patel*, Chetan A. Prajapati
Department of Quality Assurance
Pacific College of Pharmacy, Udaipur, Rajasthan, India
*bhavikpatel412@gmail.com

ABSTRACT
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for determination of Manidipine HCL. novel stability-indicating RP-HPLC method has been develop and validated for quantitative analysis of Manidipine HCL in in its pharmaceutical dosage forms using Column -Inertsil ODS 3v column (150 mm x 4.6 mm i.d., 5 μm)  with Phosphate buffer (pH-2.2) : Acetonitrile (60:40) as isocratic mobile phase at a flow rate of 1.4 ml/min and wavelength of 228 nm. The calibration curves were linear over the concentration ranges of 20-150 μg/ml for Manidipine HCL. The limit of detection (LOD) and limit of quantification (LOQ) for Manidipine HCL were 0.48 and 1.47 μg/ml.Recovery of Manidipine HCL the pharmaceutical dosage form ranged from 99.89-100.71%.
Manidipine HCL was subjected to stress conditions (Hydrolysis (acid, base), oxidation, thermal and photo degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2.


DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND DAPOXETINE HYDROCHLORIDE INCOMBINED DOSAGE FORM

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ABOUT AUTHORS:
Chetan A. Prajapati*, Bhavik S. Patel, R.Badmanaban
Department of Quality Assurance, Shri Sarvajanik Pharmacy College,
Mehsana, Gujarat, India
*prajapatichetan25@gmail.com

ABSTRACT
A novel, precise, accurate and economic high-performance thin-layer chromatographic (HPTLC) method was developed, optimized and validated for simultaneous determination of Sildenafil Citrate and Dapoxetine Hydrochloride. The chromatographic separation was performed on precoated silica gel 60 GF254 plate with hexane: methanol: diethyl amine 9.2:1.6:1.2 (v/v/v) as mobile phase. The plate was developed to distance of 8.0 cm at ambient temperature. The developed plate was scanned and quantified at their single selected wavelength of 241 nm for Sildenafil Citrate and Dapoxetine Hydrochloride. Experimental conditions such as band size, chamber saturation time, migration time of solvent front, etc. were critically studied and the optimum condition were selected. The drugs were satisfactorily resolved with RF 0.21 ± 0.02 for Sildenafil Citrate and 0.72 ± 0.02 for Dapoxetine Hydrochloride. The method was validated for linearity, accuracy, precision, and specificity. The calibration plot was linear between 2000–12000 ng per spot for Sildenafil Citrate and 1200–7200 ng per spot for Dapoxetine Hydrochloride. The limits of detection for Sildenafil Citrate and Dapoxetine Hydrochloride were 210 and 75ng per spot respectively and limit of quantification for Sildenafil Citrate and Dapoxetine Hydrochloride were 450 and 240ng per spot respectively. It is a user-friendly and important tool for analysis of combined fixed dosage forms. Methods were validated statistically and recovery studies were carried out. The method herein described can be employed for quality control and routine analysis of drugs inpharmaceutical formulations.


EDARAVONE: A REVIEW ON ANALYTICAL METHOD AND ITS DETERMINATION IN BIOLOGICAL MATRIX AND SYNTHETIC MIXTURE

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ABOUT AUTHORS:
Patel Divya .A.1*, Raj.Hasumati1, Patel Roshni2
1Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat
2Piooner College of pharmacy, Baroda, Gujarat
*divyapatel388@gmail.com

ABSTRACT
Edaravone is a potent free radical scavenger (antioxidant) mainly use in the form of injection. It is used in the treatment of various cardiovascular diseases like acute ischemic stroke as well as in gastrointestinal injuries. This review article represent the various analytical methods which has been reported for estimation of edaravone in biological matrix as well as in synthetic mixture.The spectrophotometric techniques like fluorescent assay and ratio derivative spectroscopy; Chromatogrraphic methods like HPLC, HPTLC and RP HPLC were reported.


DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF TAPENTADOL HYDROCHLORIDE

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ABOUT AUTHORS:
Shoumik Roy*, Samil D. Desai, Bhavna A. Patel, Shraddha J. Parmar
Post Graduation Department of Pharmaceutical Sciences,
Sardar Patel University, Vallabh Vidyanagar, Gujarat, India.
roy.shoumik@gmail.com

ABSTRACT
The main thrust of the paper was to develop and validate a simple, precise high performance thin-layer chromatographic (HPTLC) method for estimation of tapentadol hydrochloride in tablet dosage form. Chromatography was performed on silica gel 60 F254 plates with Chloroform: Acetone: Ammonia (2.5: 2.4: 0.1 v/v/v) as mobile phase. This mobile phase system gave a good resolution for tapentadol hydrochloride (Rf value of 0.49 ± 0.02). Detection and quantification were carried out at 272 nm. The linear regression data for the calibration plot showed a good relationship with r=0.999. The limits of detection and quantification were 62.68 and 189.94ng/spot for tapentadol hydrochloride. The amounts of the drugs in the marketed formulation were 99.98%.


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