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  • Estimation of Olmesartan Medoxomil and Atorvastatin Calcium in Tablet Dosage Form by HPLC Method

    About Authors: Venkata Suresh Babu Aluri*
    Department of pharmaceutical Analysis,
    Adhiparasakthi College of Pharmacy,
    Melmarvathur, Kancheepuram District, Tamil Nadu - 603319 (INDIA)

    Reference ID: PHARMATUTOR-ART-1077

    Abstract
    A simple, specific, sensitive, rapid, precise and economical high performance liquid chromatography (HPLC) method has been developed for the estimation of Olmesartan medoxomil (OLM) and Atorvastatin calcium (ATC) in tablet dosage form by using acetonitrile- phosphate buffer pH 3.0 (40:60 v/v) as a solvent system. The method was carried out on a Phenomenex Gemini C18 (15 cm x 4.6 mm i.d., 5µm particle size) column, at flow rate 0.9 mL/min. Detection was carried out at 252 nm. The retention time of OLM and ATC was 3.19 and 4.63 min, respectively. The two drugs follow Beer-Lambert’s law over the concentration range of 8 – 40 µg/mL for OLM and 4 – 20 µg/mL for ATC. Validation of proposed method was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The proposed method can be successfully applied in routine work for the determination of Olmesartan medoxomil and Atorvastatin calcium in combined dosage form.

  • DEVELOPMENT AND VALIDATION OF SITAGLIPTINE BY VISIBLE SPECTROPHOTOMETRIC IN BULK AND PHARMACEUTICAL DOSAGE FORMS

    About Author: V. Ranjith Kumar*, Chintalapti Sujitha
    * Department of Pharmaceutical Analysis,
    Priyadarshini college of Pharmaceutical Sciences,
    Chowdaryguda, Narapalli, Ghatkesar (Mo),
    RR-District-501301. AP-INDIA.

    Reference ID: PHARMATUTOR-ART-1062

    Abstract
    A simple, accurate, cost effective and reproducible spectrophotometric method has been developed for the estimation of Sitagliptine in bulk and pharmaceutical dosage form. Visible spectrophotometric method, which is based on measurement of absorption at maximum wavelength 540 nm. The accuracy of the methods was assessed by recovery studies and was found to be ranging from 99.5-101.5 .The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. Beers law was obeyed in the concentration range of 25-125 µg/ml having line equation y = 0.026x + 0.016 with correlation coefficient of 0.999. Results of the analysis were validated statistically and by recovery study.

  • DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM IN COMBINED DOSAGE FORM

    About Authors: MALLIKARJUNA RAO N.
    1.     Research scholar of Jawaharlal Nehru Technological University, Department of Pharmaceutical Analysis, College of Pharmacy, Kakinada, Andhra Pradesh, India.  

    Reference ID: PHARMATUTOR-ART-1042

    ABSTRACT
    Objective:
    This present study reports for the first time simultaneous quantitation of Amlodipine besylate and Atorvastatin calciumby HPTLC from a combined dosage form.
    Methods: Chromatographic separation of the drugs were performed on aluminum plates precoated with silica gel 60 F254 used as stationary phase and the chromatogram was developed using Ethyl acetate: Methanol: Ammonia (7.5 : 2 : 0.5 %v/v/v) as mobile phase. Amlodipine besylate and Atorvastatin calcium showed Rf values 0.50 ±0.02 and 0.26 ±0.02 respectively. Densiometric analysis of both the drugs was carried out in the absorbance mode at 365 nm. The method has been successfully applied to tablets and was validated according to ICH Harmonized Tripartite guidelines.
    Results: The linearity regression analysis for calibration showed 0.9983 (r2) and 0.9994 (r2) for amlodipine besylate and atorvastatin calcium with respect to peak area and height in the concentration range of 100-500ng/spot and 200-600ng/spot respectively.  The percentage recovery for amlodipine besylate was found to be 101.82 (at 50%), 99.12 (at 100%) and 101.41 (at 50%), 101.71 (at 100%) for atorvastatin calcium. The limit of detection was 30 ng/spot and    60 ng/spot for amlodipine besylate and atorvastatin calcium respectively. The limit of quantification was found to be 100 ng/spot and 200 ng/spot for amlodipine besylate and atorvastatin calcium respectively.
    Conclusion: The developed TLC technique is precise, specific and accurate. It was concluded that the developed method offered several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps and improved sensitivity made it specific, reliable and easily reproducible in any quality control set-up providing all the parameters are followed accurately for its intended use.

  • CHALLENGES IN IMPLEMENTATION OF PROCESS ANALYTICAL TECHNOLOGY (PAT) – A REVIEW

    About Author: Amit Surani,
    Dept. of Quality Assurance,

    M.Pharm, Maliba College of Pharmacy, Surat
    Gujarat Technical University

    ABSTRACT
    According to FDA, Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing process through timely measurements of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality.
    PAT involves the use of different technologies and tools to build quality into the products. Effective PAT implementation is based on detailed, science-based understanding of the physical, chemical and mechanical properties of all elements of the proposed drug product.
    Pharmaceutical companies face many challenges while implementing PAT into their new and pre-existing manufacturing processes. This article discusses the challenges encountered by manufacturers and the benefits they can reap by successful implementation of PAT.

  • Chemistry of Tamsulosin HCl and Estimation of Tamsulosin HCl by high performance liquid chromatography.

    About Authors: Kollu Varuni, B.pharm
    Vathsalya college of pharmacy,
    J.N.T.U University

    Introduction:
    Tamsulosin is a selective, potent and competitive a  1 – adrenoreceptor antagonist and has a greater affinity for these receptors, predominantly present in the human prostate. Literature survey reveals that several methods like HPLC,HPLC-MS and LC-MS were reported for the estimation of Tamsulosin hydrochloride in combination with other drugs as well as in biological fluids [1- 3]

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