International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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This journal is member of Crossref. 

1. Validated High-performance Liquid Chromatography Method for Quantitative Determination of Anthracenderivatives in Decoction, Syrup and Water-alcohol Extract of Frangula alnus Mill. Bark
Shmygareva A A, Kurkin V A, Sankov A N
Nowadays, people pay much attention to the quality of herbal medicines. Because of the significant variation in active components in them, the quality control of herbal medicines is a very important issue. High-performance liquid chromatography (HPLC) is widely used in identification and quality control of herbal medicines. A new, simple, sensitive, selective, and precise high-performance liquid chromatography (HPLC) was developed for the determination and identification of frangulin A content in “Frangula syrup”, “Frangula decoction” and “solution of aqueous-alcoholic extract from the bark of Frangula alnus”  was developed and validated. The stationary phase was inert sil C18 column. The mobile phase consisting of acetonitrile (HPLC Grade) and potassium dihydrogen phosphate buffer (pH 2.5) in a gradient flow was used. The column was equilibrated with the mobile phase (flow rate 1.0 ml/min); the UV detection was set at 420 nm. Various optimizations were performed to examine the frangulin A content in herbal medicines and their preparation including retention time, spike authentic standard, change of wavelength, change of mobile phase composition and blank test.  Using HPLC analysis we obtained the results of the quantitative determination of content of frangulin A in decoction, syrup and water-alcohol extract of Frangula alnus Mill. bark.  The content of frangulin A in decoction amounted to 6,45 µg/20 ml, in syrup amounted to 3,72 µg/20 ml, in water-alcohol extract amounted to 7,9 ml /20 µg .

2. Stability Indicating Simultaneous Validation of Telmisartan and Cilnidipine with Forced Degradation Behavior Study by RP-UPLC in Tablet Dosage Form
Reema H. Rupareliya, Hitendra S. Joshi Vijay R. Ram, Pragnesh N. Dave, Ekta Khosla
A simple, précised and accurate RP-UPLC method has been developed and validated for the simultaneous assay of Telmisartan and Cilnidipine in tablets. Isocratic RP-UPLC method was developed on LC system of Waters Acquity UPLC with PDA detector onWater Acquity BEH C18, 2.1 x 100mm, 1.7μm column as stationary phase with binary gradient mode by using mobile phase as ACN: 0.01M sodium phosphates monobasic dehydrate buffer pH 3.0 with phosphoric acid (68:32, v/v), at a flow rate of 0.5 ml/min and the detection was carried out at 245 nm. Forced degradation study was carried out by oxidation, hydrolysis, photolysis and heating the drug. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was found to be linear in the concentration range of 40-160 µg/ml with correlation coefficients of 0.9996 for Telmisartan and 10-40 µg/ml with correlation coefficients of 0.9995 for Cilnidipine. Degradation products produced as a result of stress studies did not interfere with the detection of Telmisartan and Cilnidipine: therefore, the assay can be considered to be stability-indicating.

3. Stability Indicating RP-HPLC Method for the Estimation of Metformin Hydrochloride and Repaglinide as API and Estimation in Tablet Dosage Form
Sonia K, Nappinnai M, Manikandan K
A new simple, precise, sensitive, economical RP-HPLC method was developed for the estimation of Metformin hydrochloride and Repaglinide in bulk and tablet dosage form. The λmax for Metformin hydrochloride and Repaglinide was found to be nm and nm respectively. The linearity in the concentration range of 25µg/ml to 150 µg/ml (r2=0.999) and 0.1 to 0.6 µg/ml (r2=0.999) for Metformin hydrochloride and Repaglinide respectively.  The chromatographic values for Metformin hydrochloride and Repaglinide were found to be satisfactory on BDS Hypersil 18, 250 x 4.6mm, 5µm, column using mobile phase of ACN: Buffer in the ratio of 58: 42 v/v with the flow rate of 1.0ml/min. The developed method was validated according to ICH guidelines and found to be accurate, precise, rugged and robust and found to be in good accordance with the prescribed values. The newly developed method can be used for routine analysis estimation of Metformin hydrochloride and Repaglinide in bulk and tablet dosage form in pharmaceutical industry.

4. Development and Validation of the UV-Spectrophotometric Method for Determination of Embelin
Shyam Baboo Prasad, Meenu Bist, Suraj Pal Verma
Embelin, chemically known as 2, 5-dihydroxy-3-undecyl-p-benzoquinone is one of the bioactive compound found in oldest herbal medicinal plant known as Embelia ribes. Embelin, having anti-cancer, anti-bacterial, anti-inflammatory, analgesic, hepatoprotective, antidepressant, anxiolytic, antioxidant, antifertility, antiulcer and wound healing activity. A double wavelength UV-spectrophotometric method was developed and validated for determination of embelin in Embelia ribes fruits. The standard solution of embelin in methanol shown maximum absorption at 289 nm. The response of embelin was linear over the range of 10-90 µg/ml with the correlation coefficient (R2) value of 0.9991. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 50%, 100%, and 150%. The % recovery was found in the range of 98.96– 100.9%.  The precision of the method was studied as an intraday; interday and repeatability. The % relative standard deviation (RSD) value < 2 indicate that the method was precise. The Limit of detection (LOD) and Limit of quantification (LOQ) of embelin were found 3.96 μg/mL and 12 μg/mL respectively. The method was validated using parameters provided as per International Conferences on Harmonization (ICH) guidelines.

5. Personnel Training for Pharmaceutical Industry
Deeksha R Pai, Krishnananda Kamath K, E V S Subramanyam, A. R. Shabaraya
Many of the pharmaceutical industries failed to identify the importance and necessity of quality training programs for their employees which lead to lack of development in the skill levels of employees. They even failed to judge the training level of their employees before assigning them specific responsibilities. This will reduce the quality level of skills as well as final product of the company as in compliance with the various regulations to be followed. Self-efficacy is related to the transfer of learning, knowledge and skills to the employees and is therefore an indicator of training effectiveness. The importance and necessity of evaluation, documentation and assessment of all training programs designed and practised by the industry to meet the guidelines is mentioned. This article mentions about Effective SOP training, cGMP and on the job training where a trainer can judge and plan for retraining for the personnel if necessary. The trainers whom company appoints for training shall be skilful and experienced. It is also crucial to know that ‘why training program fail’ apart from proper guidance and training methods. This article highlights about these failures and how to overcome these obstacles through proper and effective training to yield good results. Thus there is a large scope for research in training field as training itself is a bigger tool to improve the standards of industry.

UGC approved Journal

This journal is present in UGC approved List of Journals for the purpose of Career Advancement Scheme (CAS) and Direct Recruitment of Teachers and other academic staff as required under the UGC (Minimum Qualifications for Appointment of Teachers and other Academic Staff in Universities and Colleges)

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