scholarly journals An Effective Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine and Raltegravir in Bulk and Their Tablet Dosage Form

2021 ◽  
pp. 263-277
Author(s):  
Gundapaneni Ravi Kumar ◽  
Rayala Rama Rao ◽  
Vadde Megha Vardhan ◽  
V. D. N. Kumr Abbaraju
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Effective Stability ◽  
Tablet Dosage

Background: In the current study, asimple and specific stability indicating RP-HPLC method was developed and validated for the determination of Lamivudine and Raltegravir in bulk drug and it tablet dosage form using an UV-detector. Good separation was achieved by isocratic ally on a Zorbax SB-Phenyl (150 × 4.6 mm, 3.5 μ, 80 A°) column, using a mobile phase composition of buffer (0.1% v/v Phosporic acid in water): Acetonitrile (40:60 v/v) at a flow rate of 1.0 mL/min. The eluted analytes detected at 260 nm wavelength. Results: Lamivudine and Raltegravir were eluted at 3.1 and 5.4 min respectively with run time 7 min. Linearity in the method was measured in the concentration range of 30 – 70 μg/mL and 60 – 140 μg/mL for Lamivudine and Raltegravirrespectively. The percentage recoveries of Lamivudine and Raltegravirwere determined to be 100.30% and 100.53%, respectively. The validation of the developed method is carried as per USFDA and ICH guidelines, and the degradants were well resolved from Raltegravir and Lamivudine peaks. The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Conclusion: The results of the analysis prove that thedeveloped RP-HPLC method is simple, economical and widely acceptable, which can be used in routine quality control tests in the industry.

scholarly journals Development of a Validated Stability Indicating Rp-Hplc Method for the Estimation of Pirfenidone in Bulk Drug and Tablet Dosage form

2021 ◽  
pp. 110-118
Author(s):  
C. Vanitha ◽  
Sravani Singirikonda
Keyword(s):  
Thermal Degradation ◽  
Dosage Form ◽  
Hplc Method ◽  
Forced Degradation ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: The present work focused on developing a validated stability indicating RP-HPLC method for the estimation of pirfenidone in bulk drug and tablet dosage form. Methods: The chromatographic separation was performed on symmetry C18 (150 mm x 4.6, 5 micron) with a 1 ml/min flow rate at 315nm. The mobile phase employed was orthophosphoric acid buffer: acetonitrile (65:35). Column temperature was maintained at 30ºC. Pirfenidone was subjected to different forced degradation conditions according to ICH guidelines, including acid, base and neutral hydrolysis, oxidation, photolysis and thermal degradation.  Results: In alkali, acidic, oxidation and UV degradation conditions the drug shows considerable degradation. Pirfenidone was stable under neutral hydrolysis and thermal degradation. Pirfenidone was stable under extreme degradation conditions showing less than 8% of degradation in all degradation conditions. This result showed that pirfenidone was stable under stress degradation. Then the optimized method was validated for the parameters like linearity, accuracy, precision and robustness as per ICH guidelines.

STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND AZILSARTAN MEDOXOMIL IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (06) ◽  
pp. 51-61
Author(s):  
J. G Modi ◽  
◽  
J. K. Patel
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Good Resolution ◽  
Amlodipine Besylate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Azilsartan Medoxomil

A novel, simple, rapid, and highly selective stability indicating RP-HPLC method was developed and validated for simultaneous estimation of azilsartan medoxomil (AZL) and amlodipine besylate HCl (AMLO) in tablet dosage form having strength of 20 mg and 2.5 mg, respectively. The effective chromatographic separation was achieved on a Phenomenex luna ODS C18 (15 cm X 4.6 mm internal diameter, 3.5 μm Particle size) with a mobile phase composed of phosphate buffer (pH-2.5) adjusted with ortho phosphoric acid : acetonitrile in the ratio of 60:40 v/v. The mobile phase was pumped using an isocratic HPLC system at a flow rate of 0.7 mL/min with injection volume 20μl and quantification of the analytes was done at detection wavelength 254 nm. The retention times were found to be 5.918 min and 14.901 min for AMLO and AZL, respectively. The proposed HPLC method was validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, LOD, and LOQ as per ICH Q2 (R1) guideline. Calibration plots were linear over the concentration range of 75-125 µg/mL and 600-1000 µg/mL with correlation coefficients 0.9966 and 0.9948 for AMLO and AZL, respectively. Forced degradation studies were performed using hydrolysis, oxidation, photolytic, and thermal degradation conditions with good resolution between the degradants and analytes. Degradation products resulting from the stress studies did not interfere with the detection of AMLO and AZL, thus the proposed method is sensitive and stability-indicating. The validated HPLC method was successfully applied to the analysis of AMLO and AZL in tablet dosage form.

scholarly journals A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PYRANTEL PAMOATE AND PRAZIQUANTEL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 62-67 ◽  
Author(s):  
Rajesh R. ◽  
JITHU JERIN JAMES
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Pyrantel Pamoate ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage

Objective: To develop a simple, accurate and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and subsequently validate for the simultaneous estimation of praziquantel (PZQ) and pyrantel pamoate (PP) in the pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase maintained at an ambient temperature with a mobile phase comprising of water: acetonitrile (20: 80) at a flow rate of 1.0 ml/min and UV detection at 220 nm. Results: The retention time of PZQ and PP was found to be 3.897 min and 1.697 min respectively. The method was validated in terms of specificity, accuracy, precision, linearity and robustness as per ICH guidelines. Linearity was obtained in the concentration range of 20–60 μg/ml for both PZQ and PP with correlation coefficients of 0.987 and 0.998 respectively. The accuracy of the method was determined using a recovery test and found as 98.44 % to 100.35 %. All parameters are found to be within the acceptable limit. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise for the simultaneous estimation of PZQ and PP in bulk and tablet dosage form.

scholarly journals Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Hydrochlorothiazide and Losartan Potassium in Tablet Dosage Form

2012 ◽  
Vol 10 (1) ◽  
pp. 35-42
Author(s):  
Md Arif Hossen ◽  
Md Ahsanul Haque ◽  
Irin Dewan ◽  
ANM Hamidul Kabir ◽  
Md Khalid Hossain ◽  
...  
Keyword(s):  
Phosphoric Acid ◽  
Dosage Form ◽  
Hplc Method ◽  
Phosphoric Acid Solution ◽  
Losartan Potassium ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Efficient Option ◽  
Tablet Dosage

In the present study, a simple, sensitive and specific liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of hydrochlorothiazide and losartan potassium in tablet dosage form. A shim-pack CLC-ODS column (250 mm X 4.6 mm, 5μ and a mobile phase constituting 0.025 M phosphoric acid solution: acetonitrile (60:40 v/v, pH 3.0 adjusted with 80% phosphoric acid) were used. The flow rate was 1.5 ml/min and detection was carried by using ultraviolet (UV) detector at a wavelength of 254 nm. The retention times of hydrochlorothiazide and losartan potassium were 3.748 min and 8.790 min, respectively. The peaks of hydrochlorothiazide and losartan potassium were well separated (resolution 22.17). The calibration curves were linear over the concentration range of 80% to 120% (R2 > 0.999 for both the drugs). The proposed method is accurate with 100.165% recovery for hydrochlorothiazide and 100.422% recovery for losartan potassium and precise (% RSD < 0.5). The proposed method was successfully applied for the estimation of hydrochlorothiazide and losartan potassium in market products (three brands) and potency was found within limit. Therefore, this method can be a convenient and efficient option for the analysis of hydrochlorothiazide and losartan potassium in tablet dosage form. DOI: http://dx.doi.org/10.3329/dujps.v10i1.10013 DUJPS 2011; 10(1): 35-42

scholarly journals Development and Validation of RP-HPLC method for Simultaneous Estimation of Metformin and Pioglitazone

2017 ◽  
Vol 5 (01) ◽  
pp. 48-50
Author(s):  
Uttam Kumar Agrawal ◽  
Jeyabalan Govindasamy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Drug Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A new simple, accurate ,precise and reproducible RP-HPLC method has been developed for simultaneous estimation of metformin and pioglitazone in bulk drug form using proper HPLC system. The mobile phase consists of phosphate buffer and acetonitrile in the ratio of 35:65 at pH 3.4.The detection wavelength was carried out at 228 nm. The method was linear over the concentration range for metformin 50-100 μg/mL and for pioglitazone 20-180 μg/mL. The recoveries of metformin and pioglitazone were found to be 100.5 and 98.7% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method method was successfully for the analysis of pharmaceutical formulations containing dosage form.

DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (09) ◽  
pp. 53-59
Author(s):  
Girija Dandu ◽  
Basu Venkateswara Reddy
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Grade Water ◽  
Development And Validation

The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

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