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Pharmaceutical Analysis Articles
Department of Pharmaceutics,
Seth G.L. Bihani S.D. College of Technical Education Sri Ganganagar.
Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime significant impact on efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to provide effective and consistent cleaning in a given pharmaceutical production which can prevent cross contamination and adulteration of drug products with other active ingredients unintended compounds or microbiological contamination, leading prevention of several serious problems. So it is necessary to validate the cleaning procedures to ensure safety, efficacy and quality of the subsequent batches of drug product or API’s. Cleaning validation is also essential to meet regulatory requirements. The benefits of “cleaning validation” are compliance of regulatory requirements and potential problems, previously unsuspected. Which could compromise the safety and efficacy of drug products.
Bhimavarapu Ramya Reddy
Department of Pharmaceutical Analysis,
A.M Reddy Memorial College of Pharmacy, Narasaraopet,
Guntur, Andhra Pradesh, India.
One of the major challenges facing the pharmaceutical industry today is to increase the productivity, cost effective, ultimately developing new therapies that increases the human health. In order to achieve these challenges, new hyphenated analytical techniques has been employed to perform experiments in less span of time with high quality. During last decade, quantification of low molecular weight drugs by using LC-MS/MS in biological fluids is common procedure in many clinical and preclinical laboratories. Also it plays significant role in the evaluation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. This overview highlights a number of issues involving “small molecule drugs”, bioanalytical liquid Chromatography –tandem mass spectrometry, which are frequently encountered during assay development.
SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF MEROPENEM AND SULBACTAM SODIUM IN COMBINED DOSAGE FORM BY FIRST ORDER DERIVATIVE METHOD
Patel Sannil R*, Patel Satish A
Department of Quality Assurance,
Shree S. K. Patel College of Pharmaceutical Education & Research,
Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical First order derivative spectrophotometry method for the simultaneous determination of Meropenem and Sulbactam Sodium in bulk and combined dosage form. The absorbance values at 333nm and 252 nm of first derivative spectrum was used for the estimation of Meropenem and Sulbactam Sodium, respectively without mutual interference. This method obeyed beer’s law in the concentration range of 5-70 μg/ml for Meropenem and 2-21 μg/ml for Meropenem. The method was successfully applied to pharmaceutical combined dosage form because no interference from the excipients was found. The suitability of this method for the quantitative determination of Meropenem and Sulbactam Sodiumwas proved by validation. The proposed method was found to be simple and sensitive for the routine quality control analysis of Meropenem and Sulbactam Sodium in bulk and combined dosage form. The results of analysis have been validated statistically and by recovery studies.
DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND LEVOCETRIZINE DIHYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMULATION.
Gohel Bhavika A*, Patel Bhavna A, Parmar Sharddha J, Mital Sondagar M, Jadav Alpa V
P G Department of Pharmaceutical Sciences, Sardar Patel University,
V. V. Nagar, Gujarat
A new, simple, rapid and novel Spectrophotometric method has been developed for simultaneous estimation of Montelukast sodium and Levocetrizine dihydrochloride from tablet formulation. The method employs formation and solving of simultaneous equation using 230nm and 283nm as two analytical wavelengths which are absorbance maxima of Levocetrizine dihydrochloride and Montelukast sodium, respectively. The linearity was obtained in the concentration range of 5-25 g/mL for both the drugs. Recovery studies range from 98.45-100.30% for Levocetrizine dihydrochloride and 98.80-101.84% for Montelukast sodium. The results of analysis have been validated statistically and by recovery studies according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of Levocetrizine dihydrochloride and Montelukast sodium in combined dosage form.
DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE METHOD FOR ANALYSIS OF EPERISONE HYDROCHLORIDE AND LORNOXICAM IN SYNTHETIC MIXTURE
Harshil R. Patel*, Sejal K. Patel
Department of Quality Assurance,
S. K. Patel College of Pharmaceutical Education and Research,
Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical derivative spectroscopic methodfor the simultaneous determination of Eperisone Hydrochloride(EPE) and Lornoxicam (LOR) in synthetic mixture. Derivative spectroscopy offers a useful approach for the analysis of drugs in mixtures. In this study a first-derivative spectroscopic method was used for simultaneous determination of Eperisone Hydrochloride and Lornoxicam using the zero-crossing technique. The measurements were carried out at wavelengths of 264 nm and 225.2 nm for Eperisone Hydrochloride and Lornoxicam respectively. The method was found to be linear (r2>0.998) in the range of 2- 30 μg/ml for Eperisone Hydrochloride at 264 nm. The linear correlation was obtained (r2>0.996) in the range of 2-14 μg/ml for Lornoxicam at 225.2 nm. The limit of detection was 0.2565 and 0.235 μg/ml for Eperisone Hydrochloride and Lornoxicam respectively. The limit of quantification was 0.7774 and 0.7121 μg/ml respectively. The method was successfully applied for simultaneous determination of Eperisone Hydrochloride and Lornoxicam in synthetic mixture.
ANALYTICAL METHOD DEVELOPMENT OF MONTELUKAST AND FEXOFINADINE COMBINATION IN PHARMACEUTICAL DOSAGE FORM BY USING HPLC METHOD
Rituraj Singh Chundawat*, Yuvraj Singh Sarangdevot, Bhupendra Vyas, Gajendra Singh Rathore, Udaibhan Singh Rathore, Pankaj Sharma
Department of Quality Assurance, Bhupal Nobles’ College of Pharmacy,
Udaipur- 313002, Rajasthan, India
Pharmaceutical analysis may be defined as a process or a sequence of processes to identify and/or quantify a substance or drug, the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical product. HPLC is the most rapid and reliable analytical technique for analysis of drugs. Its simplicity, high specificity and wide range of sensitivity makes it ideal for analysis of many drugs in both dosage forms and biological fluids. Montelukast is a CysLT1 antagonist which blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and used in asthma. Fexofenadine competes with free histamine for binding at H1-receptors in the GI tract, large blood vessels, and bronchial smooth muscle. It blocks the action of endogenous histamine and relieves from allergy. The analytical method development of Montelukast and Fexofinadine combination in pharmaceutical dosage form is done by using HPLC method.
SIMULTANEOUS SPECTROPHOTOMETRIC ESTIMATION OF DICLOFENAC SODIUM AND EPERISONE HYDROCHLORIDE USING ABSORBANCE RATIO METHOD IN CAPSULE DOSAGE FORM
Lalit F. Raiyani*1, Dharanant V. Borakhatariya2, Bhargav D. Patel3, Kuldip R. Marwada4, Dr.Priti D. Trivedi5, Mr.Rajendra K. Patel6
1Parul institute of Pharmacy, Vadodara
2B. K. Modi Government Pharmacy College, Rajkot
3Ramanbhai Patel College of Pharmacy, Changa
4R. K. College of Pharmacy, Rajkot
5Professor at K. B. Institute of Pharmaceutical Education and Research, Gandhinagar
6Lecturer at K. B. Institute of Pharmaceutical Education and Research, Gandhinagar
A simple, rapid, sensitive, precise and accurate UV-spectrophotometric method (absorbance ratio) was developed and validated for simultaneous estimation of Diclofenac sodium and Eperisone hydrochloride in pharmaceutical capsule dosage form. In absorbance ratio method absorbance measurement of sample at 239.2 nm (isoabsorbtive point, λ1) and 256 nm, λ2.The absorbance ratio method was developed using methanol as solvent. Developed method is linear between 4-12µg/ml and 5-15µg/ml for diclofenac sodium and eperisone hydrochloride respectively. The mean % recovery was found to be 99.68% & 99.14% for diclofenac sodium and eperisone hydrochloride respectively.
METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE AND INDAPAMIDE BY DIFFERENT SPECTROPHOTOMETRIC AND RP-HPLC METHODS IN BULK DRUG AND PHARMACEUTICAL FORMULATION
Chalapathi institute of pharmaceutical sciences,
guntur, a.p, india.
Amlodipine (as besylate, mesylate or maleate) is a long-acting calcium channel blocker (dihydropyridine (DHP) class) used as an anti-hypertensive and in the treatment of angina. Indapamide is a thiazide diuretic used in the treatment of hypertension, as well as decompensated cardiac failure. Six new, simple, accurate and precise methods have been developed and validated according to ICH guidelines for the simultaneous estimation of Amlodipine and Indapamide in their combined dosage form (four UV-Spectrophotometric, one colorimetric and one RP-HPLC methods).
First method is based on simultaneous estimation using two wavelengths, 365 nm (λmaxof AMLO) and 279 nm (λmaxof INDA) by simultaneous equation method. The second method involves the use of first order derivative technique, here 293 nm, the zero crossing point of AMLO, 279 nm, the zero crossing point of INDA were used for the estimation. The third method is based on Q-absorption Ratio method using two wavelengths 365 nm (λmaxof AMLO) and 312 nm (Isoabsorptive point). In the dual wavelength method two wave lengths 270 nm and 288 nm were selected as λ1 and λ2 for the estimation of AMLO, INDA shows the same absorbance at these wavelengths. Similarly, wavelengths 350 nm and 378 nm were selected as λ1 and λ2 for the estimation of INDA, AMLO shows the same absorbance at these wavelengths.Colorimetry: The method is based on use of MBTH reagent for simultaneous estimation of AMLO and INDA using two wavelengths, 626 nm (λmaxof AMLO) and 600 nm (λmaxof INDA).
RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND DESLORATADINE IN COMBINED DOSAGE FORM
Rima M. Bankar*, Dipti B. Patel
Department of Pharmaceutical Analysis,
Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University,
Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Montelukast Sodium and Desloratadine. The method showed adequate separation for Montelukast Sodium and Desloratadine and best resolution was achieved with ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) using Acetonitrile-Methanol-Water (15:80:5, v/v) as a mobile phase at a flow rate of 1.0 ml/min and wavelength of 283 nm. The calibration curves were linear over the concentration ranges of 5-50 μg/ml for Montelukast Sodium and Desloratadine. The limit of detection (LOD) and limit of quantification (LOQ) for Montelukast Sodium were 0.33 and 1.01 μg/ml while for Desloratadine were 0.10 and 0.31 μg/ml, respectively. All the analytes were separated in less than 6.0 min. The proposed method could be applied for routinelaboratory analysis of Montelukast Sodium and Desloratadine in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.
SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM BY RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD IN SYNTHETIC MIXTURE
Rinku B Patel*1, Paresh U Patel2, Bharat G Patel3, Anil C Patel2
1Department of Pharmaceutical Analysis, Centre For Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
2Department of Quality Assurance, Centre For Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
3Aspee college of Home Science and Nutrition, S.D.Agricultural University, S.K.Nagar-385506, Banaskantha, Gujarat, India.
Simple, accurate, precise, and sensitive ratio spectra derivative spectrophotometric method for simultaneous estimation of Eperisone hydrochloride (EPE) and Diclofenac sodium(DIC) in synthetic mixture have been developed and validated. The ratio derivative spectroscopic method involves measurement of first derivative amplitude of ratio spectra at 247 nm for EPE and 218.4 nm for DIC as two wavelengths for estimation. Beer's law is obeyed in the concentration range of 2-18 μg/ml for both EPE and DIC. LOD values for EPE and DIC are found to be 0.0634 μg/ml and 0.5386 μg/ml, respectively. LOQ values for EPE and DIC are found to be 0.1921 μg/ml and 1.6321 μg/ml, respectively. The method was validated statistically and recovery studies were carried out. It was found to be accurate, precise and reproducible. The method was applied to the assay of the drugs in synthetic mixture, which were found in the range of 98.0% to 102.0% of the labeled value for both Eperisone hydrochloride and Diclofenac sodium. Hence, the method herein described can be successfully applied in quality control of synthetic mixture.
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