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Pharmaceutical Analysis Articles


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

ABOUT AUTHORS:
Palak G. Chaudhary1*, Bhavini N. Patel2, Chhagan N. Patel2, Bhanubhai N. Suhagia3
1,2Department of Quality Assurance,
Shri Sarvajanik Pharmacy College, Mehsana, Gujarat, India.
3Dean at Faculty of Pharmacy, Dharmsinh Desai University, Nadiad, Gujarat.
*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 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)

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.


FORCED DEGRADATION AND STABILITY TESTING: STRATEGIES AND ANALYTICAL PERSPECTIVES

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ABOUT AUTHORS:
U. A. Deokate, A. M. Gorde*
Dept. Of Pharmaceutical Chemistry,
Government College of Pharmacy, Hotel Vedant Road, Osmanpura,
Aurangabad, Maharashtra, India 431005
gordeanjali@gmail.com

ABSTRACT:
This review discusses the regulatory aspects of forced degradation and methodology aspects for degradant investigations. It also focuses on the prediction of degradation products and pathways and development of stability indicating assay method. While reviewing the analytical perspectives various conventional and hyphenated techniques for degradant separation and characterization are described in detail.


DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF OLMESARTAN MEDOXOMIL AND CILNIDIPINE BY SIMULTANEOUS EQUATION METHOD

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About Authors:
Nehal C. Ghelani*, Krutika Bhalodiya, Ketan Dadhania, Shital Faldu
Department of Quality Assurance
Smt. R. D. Gardi B. Pharmacy College, Rajkot, Gujarat, India
*nehalghelani10@gmail.com

Abstract
UV Spectrophotometric method has been developed for simultaneous estimation of Olmesartan Medoxomil (OLME) and Cilnidipine (CILNI) in bulk drug and in laboratory mixture. This method utilizes methanol as a solvent and λmax of Olmesartan Medoxomil and Cilnidipine selected for analysis was found to be 241 nm and 253 nm respectively. Linearity was observed in the Olmesartan Medoxomil concentration range of 4-20μg/ml and Cilnidipine concentration range 2 -10 ug/ml (r2 = 0.998 and r2 0.999) of both drugs. The accuracy and precision were determined and found to comply with ICH guidelines. This method showed good reproducibility and recovery with % RSD in the desired range. The proposed methods can be successfully applied for the routine analysis of both the drugs. This method was simple, rapid, accurate, and sensitive.


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMILORIDE AND TORSEMIDE IN THEIR COMBINED PHARMACEUTICAL DOSAGE FORM

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About Authors:
Krutika J. Bhalodiya*, Nehal Ghelani, Darshan Madiya, Shital Faldu
Department of Quality Assurance
Smt. R. D. Gardi B. Pharmacy College, Rajkot
bhalodiyakruti1@gmail.com

Abstract
UV Spectrophotometric method has been developed for simultaneous estimation of Amiloride (AML) and Torsemide (TSM) in bulk drug and in their combined dosage form by first order derivative. This method utilizes methanol as a solvent and λmax of Amiloride and Torsemide selected for analysis was found to be 248 nm(at ZCP of TSM) and 308 nm (at ZCP of AML) respectively. Linearity was observed in the concentration range of 4-14μg/ml for AML (r2 = 0.999) and 4-20 μg/ml for TSM  (r2 = 0.998). The accuracy and precision were determined and found to comply with ICH guidelines. This method showed good reproducibility and recovery with % RSD in the desired range. The proposed methods can be successfully applied for the routine analysis of both the drugs. This method was simple, rapid, accurate, and sensitive.


FLASH CHROMATOGRAPHY: AREA & APPLICATIONS

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ABOUT AUTHORS:
Ayare P*, Khanvilkar V, Chalak N
Department of Quality Assurance,
Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai
abprachi@gmail.com

ABSTRACT
Most of the sophisticated analytical techniques like NMR, MS and FT-IR need sample in the extreme pure form which is usually achieved by Preparative column chromatography but it is time consuming. From past few decades, technique called as Flash chromatography is developed which is a modification of Preparative column chromatography. This is an air pressure driven technique comprising of medium and short column chromatography, optimised for rapid separation of organic compounds. Modern flash chromatographic system consists of pre-packed plastic cartridges wherein solvent is pumped through the cartridges to achieve separation. These systems are also linked with detectors and fraction collectors which can even be automated. It is a simple, fast and economic approach to preparative liquid chromatography for purification of chemical species.This review highlights the principle involved, instrumentation, general procedure and advancement in Flash chromatography along with its applications.


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND PROPYPHENAZONE IN THEIR COMBINED PHARMACEUTICAL DOSAGE FORM

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About Authors:
Mehul Kakdiya*, Avinash Nagapara, Darshan Madiya, Shital Faldu
Department of Quality Assurance,
Smt. R. D. Gardi B. Pharmacy College, Rajkot, Gujarat, India
*kakdiyamehul@gmail.com

Abstract
A simple, precise, accurate and reproducible spectrophotometric method has been developed for  simultaneous estimation of Paracetamol (PCM) and Propyphenazone (PP) by employing first order derivative zero crossing method in Methanol. The first order derivative absorption at 249 nm (zero cross point of Paracetamol) was used for quantification of Propyphenazone and 274 nm (zero cross point of Propyphenazone) for quantification of Paracetamol. The linearity was established over the concentration range of 1-12 µg/ml and 5-24 µg/ml for Paracetamol and Propyphenazone with correlation coefficient r2 0.999 and 0.996, respectively. The mean % recoveries were found to be in the range of 100.48-102.119% and 100.448-102.713 % for Paracetamol and Propyphenazone, respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of Paracetamol and Propyphenazone in their combined pharmaceutical dosage form.


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