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. Overview of Cleaning Validation in Pharmaceutical Industry.
Anindya Ghosh, Sanjay Dey
Manufacturing  of  Pharmaceutical  drug  products  and  drug  substances  shall  demonstrate  a  control  to  reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important roll. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the impurity profile of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.

2. Simultaneous spectrophotometric estimation of Dexrabeprazole and Domperidone in capsule dosage form.
Sohan S.Chitlange, Amir I.Mulla, Ganesh R. Pawbake, Sagar B. Wankhede.
Three  UV  spectrophotometric  methods  for  the  simultaneous  determination  of  dexrabeprazole  (DEXRAB),  and domperidone (DOM), in capsules were developed in the present work. Method I is simultaneous equation method, wavelength selected are 258.5 nm (λmax for dexrabeprazole) and 286.5 nm (λmax for domperidone). Method II involves multicomponent mode of analysis, wavelength selected are 258.5 nm (λmax for dexrabeprazole) and 286.5 nm (λmax for domperidone).  Method  III  is  area  under  curve  method,  wavelength  range  selected  are  263.5-253.5  nm  for dexrabeprazole and 291.5-281.5 nm for domperidone respectively. All the methods were found linear between 5-35 μg/ml  for  dexrabeprazole  and  10-70  μg/ml  for  domperidone.  The  accuracy  and  precision  of  the  methods  were determined and validated stastically which showed no significant difference between the results obtained by the three methods. The proposed methods are highly sensitive, precise and accurate and therefore can be used for its intended purpose.

3. Quality Assessment of different variants of Yogaraj Guggulu
A K Meena, Ayushy Sachan, Ramanjeet Kaur, Bhavana Pal, M. M. Rao, Brijendra Singh, Santosh Kumar Mishra
Yogaraj-guggulu  is  a  widely  used  Ayurvedic  formulation.Standardisation  of  the  Ayurvedic  medicine,  Yogaraja guggulu has been achieved by following modern scientific quality control procedures. It has been shown to have significant  anti-inflammatory  activity  in  formaldehyde-induced  arthritis  and  in  croton  oil  granuloma.  For  the standardization of this drug physico-chemical parameters were carried out such as moisture content, ash values, extractability in water and alcohol were carried out. Thin Layer Chromatography studies were also carried out to ascertain the quality of this drug.

4. Stability Indicating RP-HPLC Method for the Estimation of Trifluoperazine Hydrochloride as API and Estimation in Tablet Dosage Forms
Deepak Sharma, Alankar Shrivastava, Deepak Duggal, Ashwin Patel
A new stability indicating method was developed for the estimation of trifluoperazine HCl in API, this method was also successfully utilized for the estimation of drug in tablet dosage forms. All the methods were utilized for the degradation of drug i.e. 0.1 N HCl, 0.1 N NaOH, 3 % H2O2, thermal and photodegradation. Drug peak was found to be seperated from all the degradants with resolution of more then two. This method was also used for the estimation of Trifluoperazine HCl in tablet dosage forms. The method was found to be simple, precise, specific and accurate. Developed HPLC method is able to separate all degradants produce form any stress condition from drug peak by resolution of more than 2. The order of stability trifluoperazine HCl was found to be H2O2<UV<alkali<acid<heat. The newly developed method can be used for routine analysis for the estimation of Trifluoperazine HCl in bulk and tablet dosage form in pharmaceutical industry.

5.Spectrophotometric Determination of Metclopramide HCl Using Solochrome Black-T
J. Dwivedi, R. Chauhan, S. Sharma, Singhal M, Yashwant, Ganesh N. Sharma
A simple and sensitive visible spectrophotometric method have been developed for the quantitative determination of Metclopromide HCl in its different dosage form (tablet, oral solution and injection). The method is based on the ion pair extraction with chloroform at pH 2.0 using Solochrome black –T as the ion pairing reagent. The spectrophotometric measurement was carried out at the absorption maximum at 505 nm. Beer’s law was obeyed in the concentration range of 5- 50 µg/ml with the reagent.  The results obtained with the proposed method are in good agreement with the labeled amounts when marketed pharmaceutical preparations are assayed. The recovery was in the range of 98.5-101.5%. Results obtained are statistically validated and found to be reproducible.

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