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Pharmaceutical Analysis Articles


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

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

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

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%.


A VALIDATED STABILITY- INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DARUNAVIR ETHANOLATE IN TABLET DOSAGE FORM

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ABOUT AUTHORS:
Palak G. Chaudhary1*, Bhavini N. Patel1, Chhagan N. Patel2
1Department of Quality Assurance,
2Department of Pharmaceutical Chemistry
Shri Sarvajanik Pharmacy College, Mehsana, Gujarat, India.
*palakc24@gmail.com

ABSTRACT
High performance liquid chromatographic method was developed and validated for the determination of Darunavir Ethanolate in tablet dosage form. The method was carried out on a Phenomenex luna C18 Column (150 × 4.6 mm id, 5µ) maintained at 30oC. The mobile phase consisted of water-acetonitrile (60 + 40, v/v) pumped at a flow rate 1.0 mL/min. Photo diode array detection was at 265 nm. The chromatographic separation was obtained with a retention time of 11.8 min, and the method was linear in the range of 1-30 µg/mL (r2 = 0.9997). The specificity and stability indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients. The method was validated for linearity, precision, accuracy, robustness, specificity, limit of detection and limit of quantitation. The developed method, after being validated was successively applied to the analysis of tablet formulations. The drug could be effectively separated from different degradation products and hence the method can be used for stability analysis.


REVIEW ON STABILITY INDICATING ASSAY METHODS (SIAMS)

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ABOUT AUTHORS:
Salma S. Quadri*, Lalit V. Sonwane, Bhagwat N. Poul, Sharada N. Kamshette
Department of Quality Assurance,
MSS’s Maharashtra College of Pharmacy, Nilanga,
Latur, Maharashtra, India.
Salmaq13@gmail.com

ABSTRACT
The main contemporary goal of stability indicating methods is to provide information about condition for stress testing so as to establish the stability of drug substances and product. This paper reviews the regulatory aspects for development of stability indicating methods. SIMs are used to differentiate the API from its potential decomposition product. Regulatory guidance in ICH Q1A (R2) ICH Q3B (R2) Q6A and FDA 21 CFR section 211 requires validated stability indicating methods. Force degradation is required to demonstrate the specificity when developing SIMs and for this reason, it should be perform prior to implementing the stability studies. Force degradation of drug standard and excipients is carried out under different conditions to determine whether the analytical method is stability indicating. The approaches for the development of stability indicating method is discussed.


DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ILAPRAZOLE AND DOMPERIDONE IN PHARMACEUTICAL DOSAGE FORM

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ABOUT AUTHORS:
R.A Tamboli, V.C. Chauhan, M.M. Pathan, S.K. Tirgar, D.A. Shah, R.R. Parmar
APMC College of Pharmaceutical Education and Research,
Motipura, Himmatngar, Gujarat
tambolirushabh@gmail.com

ABSTRACT
A specific,  accurate,  precise  and  reproducible  RP-HPLC  method  has  been  developed  and subsequently validated for the simultaneous determination of Ilaprazole and Domperidone  in pharmaceutical dosage form. The proposed HPLC method utilizes hypersil (Thermo scientific) C18 column (250 mm × 4.6 mm id, 5 μm particle size), and mobile phase consisting of methanol:phosphate buffer (40:60) and pH adjusted to 4.0 with 0.1M glacial acetic acid at a flow rate of 1.0 mL/min. Quantitation was achieved with UV detection at 230 nm based on peak area with linear calibration curves at concentration ranges 5-15 μg/ml for Ilaprazole and 15-45 μg/ml for Domperidone. The retention time of  Ilaprazole and Domperidone were found to be 3.433 min and 5.860 min respectively. The method was validated in terms of accuracy,  precision,  linearity,  limits  of detection,  limits  of  quantitation  and  robustness. This method has been successively applied to marketed formulation and no interference from the formulation excipients was found.


DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TRIAMTERENE AND BENZTHIAZIDE IN TABLETS

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ABOUT AUTHORS:
VC Chauhan*, VN Shah, DA Shah, RR Parmar
Department of Quality Assurance
APMC College of Pharmaceutical Education and Research,
Motipura, Himmatnagar, Gujarat 383001
vikas14vks@gmail.com

ABSTRACT
A  specific,  accurate,  precise  and  reproducible  RP-HPLC  method  has  been  developed  and subsequently validated for the simultaneous determination of Triamterene and Benzthiazide in tablets. The proposed HPLC method utilizes BDS hypersil (Thermo scientific) C18 column (250 mm × 4.6 mm id, 5 μm particle size), and mobile phase consisting of phosphate buffer: methanol (70:30) and pH adjusted to 3.5 with sodium hydroxide and flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 245 nm based on peak area with linear calibration curves at concentration ranges 10-30 μg/ml for Triamterene and 5-15 μg/ml for Benzthiazide. The retention time of Triamterene and Benzthiazide were found to be 5.960 min and 3.493 min respectively.  The  method  was  validated  in  terms  of  accuracy,  precision,  linearity,  limits  of detection,  limits  of  quantitation  and  robustness.  This  method  has  been  successively  applied  to tablet formulation  and  no interference  from the  formulation excipients  was found.


ABSORPTION CORRECTION SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TORSEMIDE AND AMILORIDE HYDROCHLORIDE IN THEIR COMBINED DOSAGE FORM

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ABOUT AUTHORS:
Dilip G. Maheshwari, Rujuta D. Patel*
Department of Quality Assurance,
L.J. Institute of Pharmacy, Sarkhej, Ahemdabad, Gujarat, India
*Rujutapatel09@gmail.com

ABSTRACT:
A new sensitive, simple, rapid and precise spectrophotometric method has been developed for simultaneous estimation of Torsemide and Amiloride HCl in pharmaceutical dosage form. This method was based on UV spectrophotometric determination of two drugs, using absorbance correction method. It involves measurement of absorbances at two wavelengths 288nm(λmax of Torsemide (TOR)) and 361nm (λmax of Amiloride HCl (AMI)) in methanol for the simultaneous quantitative determination of Torsemide and Amiloride HCl in the binary mixture without previous separation. The linearity was observed in the concentration range of 5 -25 μg/ml for Torsemide and 5-25 μg/ml for Amiloride HCl. The accuracy and precision of the method was determined and validated statically. The method showed good reproducibility and recovery with % RSD less than 2. Method was found to be rapid, specific, precise and accurate, can be successfully applied for the routine analysis of Torsemide and Amiloride HCl in combined dosage form without any interference by the excipients. The method was validated according to ICH guidelines.


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