This research article investigates the impact on the crystal structure of Olopatadine HCl using a... more This research article investigates the impact on the crystal structure of Olopatadine HCl using an X-ray diffractometer. During the stability study, the diffractogram obtained shows a significant shift in 2ϴ, which can be attributed to the presence of strain and preferred orientation within the crystal lattice. The study reveals that the strain is caused by lattice defects and may be due to moisture, while the preferred orientation can be attributed to the method of preparation adopted. The results indicate that the crystal structure of Olopatadine HCl is complex and requires further investigation to fully understand its properties. The findings of this study could be used to optimise the synthesis protocol and improve the material properties for various applications.
<em>Residual solvents in pharmaceutical samples are monitored using gas chromatography with... more <em>Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space</em><em> technique</em><em>.</em> <em>Based on good manufacturing practices</em><em> and regulatory requirement </em><em>measuring a residual solvent is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents Triethylamine in Piperaquine Phosphate, an active pharmaceutical ingredient was investigated</em><em> and quantified by gas Chromatograph</em><em>.The Head space gas chromatography (GC-HS) method described in this investigation utilized a DB-1, </em><em>column with dimension </em><em>30m</em> <em>X</em> <em>0.32mm ID X 3.0µm</em><em>.</em><em> The initial oven temperature was set at 40°C for 8 min and programmed at a rate of 20°C min−1 to a final temperature of 200°C for 4 min. Nitrogen </em><em>gas </em><em>was used as a carrier gas. The method was validated to be specific</em><em>ity</em><em>, linear</em><em>ity</em><em>, and precise, sensitive, rugged and showed excellent recovery.</em><em> </em>
Journal of Pharmacological Research and Developments, Jan 29, 2021
A highly sensitive analytical method is developed to determine the p-toluenesulfonylurea (PTSU) a... more A highly sensitive analytical method is developed to determine the p-toluenesulfonylurea (PTSU) and its impurities namely o-toluenesulfonamide (OTSA), p-toluenesulfonamide (PTSA) and p-toluenesulfonic acid (PTS) in Gliclazide drug substance by high performance liquid chromatography (HPLC). The developed method is validated according to the International Council for Harmonization (ICH) guidelines. The method is specific where peak purity is passing for all the impurities and were well separated. Limit of detection and limit of quantitation established for all the four impurities which is less 30% of target concentration of 0.1%. The regression coefficient found from linearity studies was greater than 0.9922 for all the four impurities. The % recovery obtained for all the impurities in Gliclazide was between 86.56% and 105.21%. Precision, repeatability and intermediate precision are established for the method by observing the relative standard deviation (RSD) which is less than 10%. The developed method can be adapted by quality control to determine and quantify these impurities in Gliclazide drug substance or drug product.
Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceut... more Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceutical industries drug development is important and critical to achieve the best quality. New drug development we should follow Quality by Design approach. Most of regulatory agency and or FDA are reviewing the drug development data. To answer such agencies and FDA we have to go towards a more scientific, risk based, holistic and proactive approach. Industrial concepts are to understand the product and manufacturing process, starting with product development, basically building quality in, not testing it. Under this concept of QbD during designing and development of a product, Now-a-days the concept of QbD can be extended to analytical techniques. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile, Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attribut...
Journal of Advances in Medical and Pharmaceutical Sciences
This paper described a rugged and precise particle size determination method that has been develo... more This paper described a rugged and precise particle size determination method that has been developed and validated for the determination of particle size distribution of Ciprofloxacin Hydrochloride by a dry method using Malvern Mastersizer 2000. The Method of the particle size distribution of Ciprofloxacin Hydrochloride was precisely developed and validated successfully. By using parameters like Precision, Intermediate precision, and Robustness the method was validated. All the particle size data has been compiled and found to be satisfactory, Hence the method is suitably used for the analysis of the Particle size analyzer of Ciprofloxacin Hydrochloride active pharmaceutical ingredients.
Aim: The aim of this present work was to design and establish an efficient synthesis of new thien... more Aim: The aim of this present work was to design and establish an efficient synthesis of new thienyl pyrazolo[1,5‐a] pyrimidines using an environmentally friendly reaction solvent. Further, the newly synthesized compounds were evaluated for antimi-crobial activity. Materials and Method: A series of thienyl pyrazolo[1,5‐a] pyrimidines have been syn-thesized by the condensation reaction of 4‐(4’‐chloro‐phenylazo)‐5‐amino pyrazole with α, β‐ unsaturated carbonyl composites (chalcones) using NaOH in polyethylene glycol-400 as a green reaction solvent. The dissemination technique recommended by the Na-tional Clinical Laboratory Standards Committee was used to study the antimicrobial ac-tivities of synthesized compounds. Results and Discussion: Polyethylene glycol-400 prompting an efficient synthesis of thienyl pyrazolo[1,5‐a] pyrimidines have been discussed. Excellent yields of the prod-ucts were obtained in a shorter reaction time using PEG 400 as a green reaction solvent. The reaction s...
This research article investigates the impact on the crystal structure of Olopatadine HCl using a... more This research article investigates the impact on the crystal structure of Olopatadine HCl using an X-ray diffractometer. During the stability study, the diffractogram obtained shows a significant shift in 2ϴ, which can be attributed to the presence of strain and preferred orientation within the crystal lattice. The study reveals that the strain is caused by lattice defects and may be due to moisture, while the preferred orientation can be attributed to the method of preparation adopted. The results indicate that the crystal structure of Olopatadine HCl is complex and requires further investigation to fully understand its properties. The findings of this study could be used to optimise the synthesis protocol and improve the material properties for various applications.
<em>Residual solvents in pharmaceutical samples are monitored using gas chromatography with... more <em>Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space</em><em> technique</em><em>.</em> <em>Based on good manufacturing practices</em><em> and regulatory requirement </em><em>measuring a residual solvent is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents Triethylamine in Piperaquine Phosphate, an active pharmaceutical ingredient was investigated</em><em> and quantified by gas Chromatograph</em><em>.The Head space gas chromatography (GC-HS) method described in this investigation utilized a DB-1, </em><em>column with dimension </em><em>30m</em> <em>X</em> <em>0.32mm ID X 3.0µm</em><em>.</em><em> The initial oven temperature was set at 40°C for 8 min and programmed at a rate of 20°C min−1 to a final temperature of 200°C for 4 min. Nitrogen </em><em>gas </em><em>was used as a carrier gas. The method was validated to be specific</em><em>ity</em><em>, linear</em><em>ity</em><em>, and precise, sensitive, rugged and showed excellent recovery.</em><em> </em>
Journal of Pharmacological Research and Developments, Jan 29, 2021
A highly sensitive analytical method is developed to determine the p-toluenesulfonylurea (PTSU) a... more A highly sensitive analytical method is developed to determine the p-toluenesulfonylurea (PTSU) and its impurities namely o-toluenesulfonamide (OTSA), p-toluenesulfonamide (PTSA) and p-toluenesulfonic acid (PTS) in Gliclazide drug substance by high performance liquid chromatography (HPLC). The developed method is validated according to the International Council for Harmonization (ICH) guidelines. The method is specific where peak purity is passing for all the impurities and were well separated. Limit of detection and limit of quantitation established for all the four impurities which is less 30% of target concentration of 0.1%. The regression coefficient found from linearity studies was greater than 0.9922 for all the four impurities. The % recovery obtained for all the impurities in Gliclazide was between 86.56% and 105.21%. Precision, repeatability and intermediate precision are established for the method by observing the relative standard deviation (RSD) which is less than 10%. The developed method can be adapted by quality control to determine and quantify these impurities in Gliclazide drug substance or drug product.
Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceut... more Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceutical industries drug development is important and critical to achieve the best quality. New drug development we should follow Quality by Design approach. Most of regulatory agency and or FDA are reviewing the drug development data. To answer such agencies and FDA we have to go towards a more scientific, risk based, holistic and proactive approach. Industrial concepts are to understand the product and manufacturing process, starting with product development, basically building quality in, not testing it. Under this concept of QbD during designing and development of a product, Now-a-days the concept of QbD can be extended to analytical techniques. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile, Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attribut...
Journal of Advances in Medical and Pharmaceutical Sciences
This paper described a rugged and precise particle size determination method that has been develo... more This paper described a rugged and precise particle size determination method that has been developed and validated for the determination of particle size distribution of Ciprofloxacin Hydrochloride by a dry method using Malvern Mastersizer 2000. The Method of the particle size distribution of Ciprofloxacin Hydrochloride was precisely developed and validated successfully. By using parameters like Precision, Intermediate precision, and Robustness the method was validated. All the particle size data has been compiled and found to be satisfactory, Hence the method is suitably used for the analysis of the Particle size analyzer of Ciprofloxacin Hydrochloride active pharmaceutical ingredients.
Aim: The aim of this present work was to design and establish an efficient synthesis of new thien... more Aim: The aim of this present work was to design and establish an efficient synthesis of new thienyl pyrazolo[1,5‐a] pyrimidines using an environmentally friendly reaction solvent. Further, the newly synthesized compounds were evaluated for antimi-crobial activity. Materials and Method: A series of thienyl pyrazolo[1,5‐a] pyrimidines have been syn-thesized by the condensation reaction of 4‐(4’‐chloro‐phenylazo)‐5‐amino pyrazole with α, β‐ unsaturated carbonyl composites (chalcones) using NaOH in polyethylene glycol-400 as a green reaction solvent. The dissemination technique recommended by the Na-tional Clinical Laboratory Standards Committee was used to study the antimicrobial ac-tivities of synthesized compounds. Results and Discussion: Polyethylene glycol-400 prompting an efficient synthesis of thienyl pyrazolo[1,5‐a] pyrimidines have been discussed. Excellent yields of the prod-ucts were obtained in a shorter reaction time using PEG 400 as a green reaction solvent. The reaction s...
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Papers by Amit Gosar